Driving The Power of Innate and Adaptive Tumor Immunity
About Us
Turnstone Biologics’ mission is to deliver breakthrough cancer immunotherapies by advancing two leading and complementary platforms targeting tumor immunity, to improve survival for people with cancer.
Turnstone Biologics is a privately-held clinical stage biotech company with offices in New York City (USA), San Diego (USA) and Ottawa (Canada). Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity plus local expression of encoded therapeutics, while the TIL cell therapy platform leverages clinically validated protocols to add industry-leading cell selection strategies. Our development programs drive innate and adaptive tumor immunity to provide benefit to the millions of cancer patients underserved by current treatment options.
Our scientific founders, Drs. John Bell, David Stojdl and Brian Lichty, are world leaders in the oncology and immunotherapy fields. Collectively, they have authored more than 200 publications in leading journals, and have spent years engineering and developing technologies to create the next generation of powerful, targeted therapies for cancer patients.
Our passionate team of leaders in oncology have decades of experience in biotechnology, academia and pharmaceutical drug development. With comprehensive capabilities in immuno-oncology discovery, basic research, translation, clinical development, manufacturing, and commercialization, we are committed to bringing new medicines to people with cancer to improve their lives.
Our Science
Turnstone Biologics is focused on driving innate and adaptive tumor immunity through the development of two independent, yet complementary platforms, built on a foundation of validated clinical success.
Turnstone’s proprietary vaccinia virus platform has been engineered to stimulate the immune system, drive antigen presentation and recognition, and re-shape the tumor microenvironment. The high degree of tumor selectivity and large transgene capacity of the virus can be utilized to deliver other agents and therapeutics directly to sites of tumors throughout the body for local expression, reducing their potential for systemic toxicity.
There has been strong clinical evidence demonstrating the benefit of TIL therapy in solid tumors, however, driving clinical benefit in harder to treat, lower mutational burden cancer indications, is the next needed innovation in the field. Turnstone’s proprietary TIL platform combines leading methods for identifying relevant tumor reactive T cells from TILs with the latest advancements in cell sorting and cell rejuvenation, enabling rapid advancement of these highly promising enriched T cell therapies to address a broad range of solid tumors.
Pipeline
Turnstone is developing two highly innovative and complementary therapeutic platforms. Our RIVAL pipeline is derived from our viral immunotherapy platform, with the lead RIVAL-01 program in early clinical development. Our TIDAL pipeline is derived from our cell therapy platform, with the lead TIDAL-01 program expected to enter the clinic by early 2022.
Leadership
Turnstone Biologics was founded by world-leading experts in cancer immunotherapies who have defined and advanced the field over the course of multiple decades. Our leadership team includes experts from academia and the life sciences industry who share the vision of bringing innovative immunotherapies based on our unique viral and TIL therapy platforms to people with cancer.
Sammy Farah, PhD, MBA
President & Chief Executive Officer
Dr. Sammy Farah has extensive vaccine expertise and almost 20 years of scientific, business and executive management experience in the biotechnology industry. He joined Turnstone Biologics from Synthetic Genomics Vaccines, Inc., where he served as President. Prior to that, he was Chief Business Officer of Immune Design Corp. And before then, Sammy was at Versant Ventures where he specialized in biotechnology investing and new company formation, and at Merck & Co., Inc. where he led technology support for multiple commercial vaccine franchises before joining the business development and licensing group to evaluate and execute new external technology and research partnerships. Dr. Farah earned an M.B.A. from the Wharton School at the University of Pennsylvania, a Ph.D. in biochemical engineering from Stanford University, and a B.S. in biochemical engineering from the Massachusetts Institute of Technology.
Stewart Abbot, PhD
Chief Scientific Officer
Dr. Abbot has more than 20 years of research and development experience in cell-based products and leads Turnstone’s R&D organization. He joined Turnstone from Adicet Bio where he was Chief Scientific and Chief Operating Officer, responsible for R&D activities for allogeneic gamma delta T cell therapies. Prior to this, Dr Abbot served as Chief Development Officer at Fate Therapeutics and oversaw development of hematopoietic and induced pluripotent stem cell-based immunotherapeutics. His previous roles included Executive Director of Integrative Research and Senior Director of Research at Celgene, where he led technology and cell therapy product scouting, alliance identification and business development activities, initiated engineered T cell programs, and developed novel therapeutic candidates based on hematopoietic stem cells and human placenta-derived cells; and Head of the Molecular and Cellular Biology research group for GE Global Research at General Electric. Dr. Abbot holds a B.Sc. in Biological Sciences from the University of Edinburgh, M.Sc. in Biomedical Engineering from the University of Strathclyde in Glasgow, and Ph.D. in Pathology from the University of London.
Saryah Azmat
Chief Business Officer
Ms. Azmat leads business development, corporate strategy, and capital formation at Turnstone. Her contributions and leadership have been critical to the growth of the business, including Turnstone’s recent acquisition of Myst Therapeutics and ongoing investor relations activities. Ms. Azmat joined Turnstone from Bristol-Myers Squibb (“BMS”), where she was the Global Lead for Oncology Search & Evaluation. During her six-year tenure at BMS, Ms. Azmat executed over 15 major transactions spanning all stages of preclinical and clinical development. Prior to BMS, she was a consultant for global biopharma clients at Putnam Associates, where she managed clinical and commercial stage projects. Ms. Azmat earned a B.A. in engineering sciences and a B.E. in biomedical engineering from the Thayer School of Engineering at Dartmouth College.
Steve Bernstein, MD
Chief Translational Officer
Steven Bernstein, M.D., has more than 20 years of experience as a treating physician, translational scientist and pharmaceutical executive. Prior to joining Turnstone, Dr. Bernstein served as Chair, Immuno-Oncology Translational Research and Development, and Head, Integrated Science, at Bristol-Myers Squibb. Prior to BMS, he was as an academic physician scientist most recently at the University of Rochester’s James P. Wilmot Cancer Institute, where he was Professor of Medicine, Co-Director of the Hematological Malignancy and Lymphoma Biology Programs and Co-PI of the University of Rochester/Arizona Cancer Center NCI SPORE grant in lymphoma. Dr. Bernstein was a member of the Lymphoma Working Group of SWOG, and the Scientific Advisory Boards of both the Lymphoma Research Foundation and the Leukemia and Lymphoma Society.
P. Joseph Campisi, Jr., Esq.
General Counsel
Joseph serves as Senior Vice President and General Counsel, bringing to Turnstone more than 30 years of experience in mergers and acquisitions, collaborations, and securities offerings and corporate governance. Joseph joined Turnstone from Scorpion Therapeutics where he was Executive Vice President, General Counsel and Secretary. Prior to this, Joseph was Senior Vice President and Deputy General Counsel at Bristol-Myers Squibb (“BMS”), where he oversaw the Transactional Practice Group of the BMS Law Department. During more than 16 years at BMS, Joseph was responsible for the completion of over 100 strategic transactions, including the sale of BMS Medical Imaging, the divestiture of the BMS diabetes business, the sale of ConvaTec, and the initial public offering and subsequent split-off of Mead Johnson Nutrition, as well as the acquisitions of Medarex, Inc. and Celgene Corporation. Before BMS, Joseph was a partner at the law firm Pillsbury Winthrop Shaw Pitman LLP, where he was a member of the firm’s Corporate and Securities and Life Sciences practice groups, and spent time in the firm’s offices in New York, London, Hong Kong and San Francisco during his 13-year tenure there. Joseph obtained a Juris Doctor with distinction from Hofstra University School of Law, a Master of Business Administration (Finance), and a Bachelor of Science (Accounting) from St. John’s University. He is admitted to the bar in both the State of New York and the State of California and is licensed in the State of New York as a Certified Public Accountant (inactive).
José Manuel Otero, PhD
Chief Technology Officer
Dr. Otero heads bioprocess development, manufacturing, and CMC at Turnstone, across both viral and cell-based therapies, bringing with him nearly 20 years of industry experience in vaccines and complex biologics. He joined Turnstone from Seres Therapeutics, Inc., where he was Vice President of Bioprocess Development and Manufacturing. Dr. Otero oversaw expansion of the group and was the team leader for the first synthetic microbiome therapy to enter clinical studies in the U.S. Dr. Otero started his career at Merck & Co., Inc., where he was Head of Fermentation Development before becoming a Director of Engineering to support multiple commercial vaccine franchises. He earned a Ph.D. in chemical and biological engineering from Chalmers University of Technology, and an M.Eng. in biomedical engineering and a B.S. in chemical engineering from the Massachusetts Institute of Technology.
David Stojdl, PhD
SVP, Discovery Research
Dr. David Stojdl pioneered the exploration of host-virus interactions critical to oncolytic therapy to guide the clinical development of more effective virus platforms. At the Ottawa Regional Cancer Centre, he first identified VSV as an oncolytic virus and defined the archetypal role of interferon signaling in tumor-specific oncolytic virus targeting. Since joining the CHEO Research Institute in 2004, Dr. Stojdl has discovered and developed several novel oncolytic vector platforms, including the Maraba oncolytic virus platform. Dr. Stojdl also directs the CHEO Automated Screening Centre (CASC), leveraging state-of-the-art high-throughput robotic screening technology to uncover new insights for the clinical development of oncolytic virus biotherapies. Dr. Stojdl is a professor in the Department of Pediatrics and Department of Biochemistry, Microbiology and Immunology at the University of Ottawa. He was a scientific co-founder and consultant to Jennerex Biotherapeutics (later acquired by SillaJen Biotherapeutics). He received a Ph.D. from the University of Ottawa and an M.S. and B.S. in microbiology and immunology from the University of Western Ontario.
TJ Langer
SVP, Cell Therapy Development and External Innovation
TJ Langer is SVP of Cell Therapy Development and External Innovation and brings with him more than 16 years of biopharma product discovery, development and commercialization experience to Turnstone. TJ was the CEO of Myst Therapeutics before it was acquired by Turnstone in 2020, a biotech company he founded which pioneered novel cellular immunotherapies based on tumor infiltrating lymphocytes (TIL) for the treatment of solid tumors. Prior to Myst, TJ was responsible for the development of cell therapy at Kite Pharma and was influential in progressing YESCARTA® from pre-IND through to post-BLA approval. He subsequently led the development of engineered TCR cell therapy targeting patient specific neoantigens following Gilead’s acquisition of Kite. TJ earned a B.E. in Biomedical Engineering from Vanderbilt University.
Maura Campbell, PhD
VP, Intellectual Property & Contracts
Dr. Maura Campbell has spent more than 20 years in technology transfer and the management and commercialization of intellectual property (IP). She has business management experience in all key sectors of biotech, including private and public companies, universities and research institutes, and government-funded public sector research organizations (National Centre of Excellence [NCE]). Maura joined Turnstone Biologics from VBI Vaccines where she served as Director, Intellectual Property. She also was with the Ottawa Hospital Research Institute (OHRI) as a Senior Research Program Manager, where she oversaw the oncolytic vaccine project commercialization. Earlier in her career, Maura was the Director of Intellectual Property for PainCeptor Pharma Corporation, the Manager of Technology Transfer & Commercialization for the OHRI, and the Manager of Technology Transfer at the Institute for Robotics and Intelligent Systems at NCE. She has served as an IP consultant to a number of Canadian start-ups including Neurochem, Conjuchem, Aonix, AMRIC and Sussex Research Labs. Maura received a Ph.D. in biochemistry from the University of Ottawa, and an M.Sc. and a B.Sc. in biochemistry from Queen’s University in Kingston.
Karen Major
VP, Regulatory
Karen Major has 18 years of Regulatory Affairs experience, specializing in the global development of biotechnological oncology products. Prior to joining Turnstone, she was Sr. Director Regulatory Affairs at Arbutus Biopharma, focusing on chronic HBV. Prior to that, she held the same position at Tekmira Pharmaceuticals, developing siRNA-LNP products in oncology, infectious disease and metabolic indications. Karen led the Regulatory Affairs departments at YM BioSciences (acquired by Gilead in 2013) and Viventia Biotechnologies. Karen holds an honors BSc in Pharmacology and Toxicology from the University of Toronto, a post-graduate diploma in Regulatory Affairs and Quality Operations from Seneca College, and a Regulatory Affairs Certification (RAC) from RAPS.
Adina Pelusio
VP, Clinical Operations
Adina Pelusio has more than 15 years of experience in drug development, most recently as the Vice President, Clinical Operations at SillaJen Biotherapeutics (formerly Jennerex, Inc), where she spent a decade advancing oncolytic viruses in clinical trials. In addition to overseeing the Clinical Operations department at SillaJen, she managed and pioneered the medical educator role to expand hospital personnel comfort and knowledge globally with oncolytic viruses. Prior to Jennerex, Ms. Pelusio served as a SWAT Senior Clinical Research Associate at PPD, a large, global CRO, where she was tasked with study rescue and served on a technology committee assigned with developing training for CRAs and project teams on new technologies within the field.
Jerel Davis, PhD
Chairman & Director,
Versant Ventures
Dr. Jerel Davis is a Managing Director at Versant Ventures and is based in Vancouver. Since joining Versant in 2011, he has played a critical role in launching and investing in a number of Versant’s portfolio companies including Quanticel Pharmaceuticals, Crispr Therapeutics, Blueline Bioscience, Northern Biologics and several of the Inception Sciences discovery start-ups. He has also led Versant’s execution of build-to-buy structured acquisitions with Celgene, Roche and Bayer. Over the last few years, Jerel has focused on establishing Versant’s presence in Canada, including the launch of new companies in Vancouver, Toronto and Montreal. Prior to joining Versant, Jerel was Associate Principal at McKinsey and Company where he advised pharmaceutical, biotechnology, medical device and molecular diagnostics companies. He has worked in a number of healthcare markets globally including the United States, Europe, China, Russia and India. Jerel was a post-doctoral researcher at Stanford University and worked in research at Amgen.
Brad Bolzon, PhD
Director,
Versant Ventures
Brad Bolzon, Ph.D., is a Managing Director and Chairman of Versant. He combines 13 years of global pharmaceutical industry experience and a similar tenure as a venture capitalist. Brad is the architect of Versant’s investment strategy. His track record consists of successive outlier returns including Amira (sale), Okairos (sale), Speedel (sale), Quanticel (sale), Novira (sale), Flexion (2014 IPO), Crispr (2016 IPO), BioTie (sale), Jecure (sale), Inception (multiple sales) and BlueRock (sale), and he continues to manage several other promising investments.
Prior to joining Versant, Brad served as Executive Vice President, Global Head of Business Development, Licensing & Alliances at Roche. Under his leadership, Roche established alliances with over 75 venture-backed biotech companies worldwide and transformed its R&D pipeline into an industry leader. Prior to that, Brad held executive roles at Eli Lilly in drug discovery, clinical research, regulatory affairs and business development. He earned Master of Science and Ph.D. degrees in Pharmacology from the University of Toronto.
Mike Burgess, MBChB, PhD
Executive Director,
Turnstone Biologics, SpringWorks Therapeutics
Dr. Mike Burgess brings 20 years of drug research and development experience to Turnstone Biologics. At Bristol-Myers Squibb, he led strategy and execution of translational medicine, early-stage clinical trials and clinical pharmacology across all therapeutic areas, including oncology. Prior to this at Roche, Mike held several different senior leadership positions, including acting global head of Roche Pharma Research and Early Development (pRED) and Senior Vice President and Global Head of Oncology Research and Early Development. Before joining Roche, Mike spent 7 years at Lilly working on early stage oncology trials. Mike received his medical degree (MBChB) and a Ph.D. in molecular biology from the University of Bristol, UK and spent 10 years as a practicing physician in pediatrics and pediatric oncology.
Sammy Farah, PhD, MBA
Director,
Turnstone Biologics
Dr. Sammy Farah has extensive vaccine expertise and almost 20 years of scientific, business and executive management experience in the biotechnology industry. He joined Turnstone Biologics from Synthetic Genomics Vaccines, Inc., where he served as President. Prior to that, he was Chief Business Officer of Immune Design Corp. And before then, Sammy was at Versant Ventures where he specialized in biotechnology investing and new company formation, and at Merck & Co., Inc. where he led technology support for multiple commercial vaccine franchises before joining the business development and licensing group to evaluate and execute new external technology and research partnerships. Dr. Farah earned an M.B.A. from the Wharton School at the University of Pennsylvania, a Ph.D. in biochemical engineering from Stanford University, and a B.S. in biochemical engineering from the Massachusetts Institute of Technology.
Robert Gould
Director,
Fulcrum Therapeutics
Robert Gould joined Fulcrum as president and CEO at the time of the company’s launch in 2016, bringing over 30 years of experience to the role. Previously, he served as president and CEO of Epizyme from 2010 to 2015. Prior to joining Epizyme, Robert served as director of novel therapeutics at the Broad Institute of MIT and Harvard from 2006 to 2010. Robert spent 23 years at Merck where he held a variety of leadership positions, culminating in the role of vice president, licensing and external research. Throughout his time at Merck, Robert was instrumental in advancing more than 20 compounds from discovery into clinical development in multiple therapeutic areas. Robert received a B.A. from Spring Arbor College and a Ph.D. from the University of Iowa and completed postdoctoral studies at the Johns Hopkins University.
Rishi Gupta, JD
Director,
OrbiMed
Rishi Gupta is a private equity partner at OrbiMed. Prior to that, he was a healthcare investment banker at Raymond James & Associates, served as manager of corporate development at Veritas Medicine and was a summer associate at Wachtell, Lipton, Rosen & Katz. Rishi has published scientific articles on the mechanisms of HIV entry into host cells and legal articles on intellectual property laws in the developing world. In addition to Turnstone Biologics, he serves or has served on the boards of Dimension Therapeutics, Symbiomix Therapeutics, Avitide, Verona Pharma, ChemoCentryx and Sientra. He has also been actively involved with OrbiMed’s investments in Acceleron Pharma, CoGenesys, Supernus Pharmaceuticals, Adimab, Receptos, Aragon Pharmaceuticals, Seragon Pharmaceuticals, Alector, Arsanis, Biotie, Invitae and ORIC Pharmaceuticals. Rishi earned a J.D. from the Yale Law School and an A.B. degree magna cum laude in biochemical sciences from Harvard College.
Stefan Larson, PhD
Director,
Sectoral Asset Management
Dr. Larson joined Sectoral in 2018 as Partner – Private Equity, responsible for leading biotechnology private equity investments. Prior to joining Sectoral, Dr. Larson was an Entrepreneur-in-Residence and later Venture Partner with Versant Ventures, where he led the establishment of their Toronto-based Discovery Engine and was the founding CEO of Northern Biologics. Dr. Larson was also a co-founder of two medical device companies: Perimeter Medical Imaging, and Tornado Spectral Systems. He began his career at McKinsey & Company in San Francisco and Toronto. Dr. Larson received his B.Sc. in Biology from McGill University, and his M.Sc. in Molecular and Medical Genetics from the University of Toronto, prior to completing his Ph.D. in Biophysics at Stanford University.
Patrick Machado
Director,
Former CFO/CBO Medivation
Patrick Machado is a co-founder of Medivation, Inc., a biopharmaceutical company, and has served on its Board of Directors since April 2014. Prior to his retirement in April 2014, Mr. Machado served as Medivation’s Chief Financial Officer since its inception in September 2003 and as its Chief Business Officer since December 2009. From 1998 until 2001, Mr. Machado was employed by ProDuct Health, Inc., a privately-held medical device company, as Vice President, Chief Financial Officer and General Counsel from 1998 to 2000, and as Senior Vice President and Chief Financial Officer from 2000 to 2001. From 2001 until 2002, Mr. Machado served as a consultant to Cytyc Corporation, to assist with transitional matters related to Cytyc Corporation’s acquisition of ProDuct Health, Inc. Mr. Machado received a J.D. from Harvard Law School and a B.A. and B.S. in German and Economics, respectively, from Santa Clara University.
Santhosh Palani, PhD
Partner,
PFM Health Sciences
Santhosh is a Partner at PFM Health Sciences, where he invests in private and public biotechnology companies. He has served on the boards of companies in gene editing, cell therapy, and targeted oncology fields. Previously, he was a Principal at New Enterprise Associates (NEA), where he invested in early-stage private companies in the biopharmaceutical sector. Prior to that, he was a Vice President at Cowen and Company in Equity Research, where he covered SMID Cap Biotechnology stocks. He previously served as an Associate Director in oncology clinical development at Pfizer, and as a Scientist in oncology preclinical development at Takeda Pharmaceuticals (Millennium). He earned his PhD in Bioengineering from the University of Pennsylvania and completed his postdoctoral work in Biochemistry and Molecular Biophysics at Columbia University. He is a CFA® Charterholder.
Jeff Courtney
In Memoriam
Jeff Courtney helped to form Turnstone Biologics and was an outstanding leader for FACIT (Fight Against Cancer Innovation Trust). Jeff’s life’s work and warm personality inspires all of us at Turnstone Biologics to drive forward our mission to help cancer patients, and we greatly miss his presence, leadership and friendship.
Partners
We are backed by top-tier life science and biotech investors and are partnered with institutions who are committed to Turnstone’s growth and advancing transformative technologies that meaningfully alter the treatment paradigm of cancer therapy. Since our inception in 2015, we have raised more than $360 million in venture capital and non-dilutive financing and secured partnerships with major biopharmaceutical companies, including a billion-dollar deal with Takeda Pharmaceutical Company Limited.
In December 2019, Turnstone Biologics announced a global collaboration and license agreement with Takeda to develop novel viral immunotherapies from Turnstone’s proprietary vaccinia virus platform for a broad range of cancer indications.
News
Careers
We continue to build a world-class team of specialists as we collaborate to transform cancer care. If you’re a passionate person, and our mission and science excite you, Turnstone Biologics might be for you.
Turnstone Biologics’ team works with a sense of urgency to fulfill our mission. Our decision-making is driven by science and our therapeutics are designed with the patient in mind. We value transparency, innovation, integrity and purpose. Our employees, with their relentless drive and expertise, are the basis of our success.
Team Opportunities
Turnstone Biologics is dedicated to excellence and innovation in every aspect of our science and business. We are actively looking for exceptional individuals who share our passion for developing and delivering next-generation cancer immunotherapies. We offer competitive compensation and benefits and are an equal opportunity employer.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
Turnstone is seeking a Research Associate to join our team of immunologists driving the development of our growing pipeline of T cell and oncolytic virus immunotherapies. This is an exciting opportunity to work along side senior researchers and project teams to perform discovery and development research that will ultimately create new medicines for cancer patients.
Turnstone’s T Cell therapy technology is based around a powerful new Selected-TIL process that revolutionizes the generation of tumour targeted T cells for adoptive cell therapy. Your role will be to work with a team of immunologists and molecular biologists to invent and develop these next gen T cell products for preclinical and clinical evaluation. There will be additional opportunities to continually refine the technology and manufacturing processes for this class defining therapy. If you have experience with T cell manipulation, engineering and culture, then this opportunity may be just what you are looking for.
You will work along side senior researchers and supporting technical colleagues within project teams at our state of the art facilities in San Diego and participate in designing and executing cell-based human immunology studies following established laboratory standard operating procedures (SOPs). We have an open, transparent and dynamic culture that embraces scientific excellence, integrity, urgency, partnerships with key stakeholders and continuous learning/improvements.
In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size and growth we will give you plenty of opportunities for you to be an inspirational and collaborative co-functional leader. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!
We are in the early stages of building strategies, structures and process so this role will be busy and expanding. We also have opportunities for you to be a mentor to other team members. You would have the opportunity to create something new and grow your career right along with the company.
The Responsibilities include the following:
-Drive various aspects of in vitro and in vivo studies including but not limited to: designing and executing experiments, organizing teams, scheduling and managing complex multi-disciplinary experiments including data collection, analysis, and interpretation.
-Prepare data/figures to present to senior research staff
-Generate study reports in a timely manner
-Write and review SOPs
-Contribute to a team-centric culture that embraces scientific excellence, integrity, and urgency
Experience:
-Degree in Immunology/Microbiology/Biochemistry (research primarily focused in immunology) with recent biotech or pharmaceutical industry experience preferred
-Extensive experience with immune assays including flow cytometry, ELISA, ELISPOT, immune cell culture and common molecular techniques.
-Experience with T cell engineering is highly desirable
-Experience studying T cell metabolism and cell state is a plus
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
Turnstone’s T Cell therapy technology is based around an exciting new Selected-TIL process that revolutionizes the generation of tumour targeted T cells for adoptive cell therapy. Your role will be to join a team of immunologists and molecular biologists who invent and develop these next gen T cell products for preclinical and clinical evaluation. There will be additional opportunities to continually refine the technology and manufacturing processes for this class defining therapy. If you have experience with T cell manipulation, engineering and culture then this opportunity may be just what you are looking for.
You will work along side senior researchers and supporting technical colleagues within project teams at our state of the art facilities in San Diego and participate in designing and executing cell-based human immunology studies following established laboratory standard operating procedures (SOPs). We have an open, transparent and dynamic culture that embraces scientific excellence, integrity, urgency, partnerships with key stakeholders and continuous learning/improvements.
What’s in it for you?
In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size and growth we will give you plenty of opportunities for you to be an inspirational and collaborative co-functional leader. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!
We are in the early stages of building strategies, structures and process so this role will be busy and expanding. We also have opportunities for you to be a mentor to other team members. You would have the opportunity to create something new and grow your career right along with the company.
The Responsibilities include the following:
-Design and execution of in vitro and in vivo studies to understand T cell activity, function, cell state and phenotype from human and rodent tissues
-Participate individually or as part of project teams to schedule and manage complex multi-disciplinary experiments including data collection, analysis, and interpretation.
-Prepare data/figures and presentations to communicate results from experiments to senior research staff
-Generate study reports in a timely manner
-Write and review SOPs and overseeing training for team members
-Contribute to a team-centric culture that embraces scientific excellence, integrity, and urgency
Experience:
-Ph.D. in Immunology/Microbiology/Biochemistry (research primarily focused in immunology) with post graduate experience or and/or biotech or pharmaceutical industry experience
· This role will be positioned out of our new San Diego site
-Deep knowledge and experience in T cell function/differentiation/signaling/regulation, metabolism/phenotypic analysis of inhibitory and costimulatory targets and pathways and/or neoantigen biology and vaccines is highly preferred.
-Robust understanding of innate and adaptive immune systems is required
-An expert knowledge of immune based in vitro assays, flow cytometry and common molecular techniques such as cell based and biochemical assays to interrogate the immunological mileu of human blood tissue or tumour samples, including ICS, ELISpot assay, ELISA, RNA seq
-Experience with T cell engineering highly preferred
-Experience studying T cell metabolism and cell state highly preferred
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
• Team lead for T cell -based therapy optimization and discovery research
• Lead and execute a program of genetic and epigenetic augmentation of primary human T cells
• Oversee planning and execution of all in vitro T cell functional assays, including signal transduction via TCR and target killing
• Develop and mentor a high-performance team of scientific and technical experts to create industry-leading T cell-based therapies in solid tumor indications.
• Support the interface between other Research, Cell Process Development, CMC, Clinical, Regulatory, and Quality functions to align the product strategy with program, portfolio, and corporate goals
• Lead the establishment of new process-relevant methods, SOPs, and oversee training of team.
• Responsible for maintaining a culture of scientific integrity and excellence in execution, data analysis, visualization, and presentation
Requirements
• PhD in Immunology with 8+ years of postdoctoral experience in T cell biology, including at least 3+ years of management experience
• The primary location for this role is our new San Diego site, but one of our sites in Canada could be considered based on the candidate’s needs
• Willingness to travel (when it’s safe as it pertains to global pandemics) up to 25% to other Turnstone sites
• Significant scientific accomplishment as evidenced by developed products or core contributions to publications
• Strong scientific track-record demonstrating well organized design and execution of immunology studies
• Broad theoretical and practical knowledge in the fields of T Cell Immunology and Cancer Biology
• Detailed knowledge of T cell biology, including structure, function and signal transduction of T cell receptors, metabolism, and tumor microenvironment
• Deep knowledge and extensive hands-on experience in methodologies, reagents and instrumentation used for T cell isolation, functional characterization, T cell phenotyping and cytotoxicity measurement
• Expertise with TCR mapping, cloning, and screening is a plus
• Experience with human and mouse in vitro and in vivo immunology model development and application
• A keen ability to build an organization, and help manage the dynamics of change within a rapidly growing company
• Strong interpersonal skills with the ability to motivate, influence, and find solutions with others
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all team members
• Experience with ELN and LIMS systems is a plus
• Familiarity with lab automation is a plus
• An excellent work ethic and willingness to work collaboratively in a fast-paced work environment are essential
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
This role will be responsible for elevating the Program Leadership/Project Management and Alliance Management functions to ensure creation of the program plans and budgets, as well as day-to-day planning, coordinating and tracking of critical activities. You will be responsible for providing critical Program/Project Management expertise and support to Turnstone Biologics internal programs and strategic partnerships to ensure all Program / Project milestones and deliverables are met, and that tasks are well managed and executed. You will also be responsible for driving the program timelines to keep them on schedule and within budget. Additional coordination responsibilities, as highlighted in more detail below, also include planning, facilitating, and following-up on regular program team meetings; anticipating and managing potential program issues; understanding the scope, schedule and resources for the program; utilization of Gantt charts and other project management tools to facilitate communication within the team, across the organization, and with external collaborators.
RESPONSIBILITIES
· Oversee internal program leadership, project management and alliance management
· Partner with the Program Leaders, project and alliance managers to optimize team effectiveness and decision making
· Coordinate the management of internal and external programs including project planning, progress tracking and budget planning & tracking
· Interface internally by acting as a liaison and facilitator of cross functional teams (i.e., Clinical Development, Clinical Operations, Technical Operations, Regulatory, Quality Assurance, Finance, etc.) in planning and executing trials
· Champion the development of the Program Leadership Department through introduction of new tools and processes for continuous improvement
· Sets key performance indicators and create timelines for driving internal and external programs on schedule.
· Facilitate highly effective team building and communication
· Proactively and independently, identifies and resolves program team challenges
· Perform effective risk management assessments with the Program Team, the Program Leader, and stakeholders
· Drive information flow and communicates program status to all stakeholders in collaboration with the Program Leaders and Project Managers.
· Coordinate production of regular status reports (milestones, status, issues, decisions), following review by the Program Leader and Program Team, for executive and senior management
· Coordinate portfolio reviews
· Support program knowledge management and data integrity procedures
· Partner with business development to initiate strategic relationships
· Manage and optimize the value of our strategic alliances across research, development and clinical
· Function as the internal and external point of contact for collaboration management and progress
· Support sponsored research contract execution
· Interface externally with collaborators, vendors, contractors, and consultants to ensure communication and deliverables in accordance with planned program objectives
· Identify platform, program and product issues
· Support regulatory filings
· Support setting of program strategy
· Support corporate financing initiatives
· Mentor and develops program leadership & management group members
Experience & Qualifications:
Minimum of a BA/BS is required, while an advanced degree (PharmD, PhD) is highly desirable.
· 10+ years of work experience, 8-10 years of Program/Project or Alliance Management experience, preferably within a matrixed pharmaceutical, biotechnology or medical device organization
· Extensive project planning experience required, especially an understanding of the clinical development and product commercialization processes. PM Certification is a plus
· Oncology experience is highly desirable.
· Advanced (gene or cell) therapy experience is highly desirable.
· Proactive mindset with strong formal and informal leadership, facilitation, teamwork and influence management/negotiation skills.
· Must have excellent verbal and written communication skills as well as exceptional organizational capability.
· Prior experience in leading and managing interdisciplinary or cross functional pharmaceutical or biotech teams is required.
· Ability to drive program plans and timelines (across multiple functional areas) is essential
· Proven success in goal setting, prioritization and time management is required
· Understanding of FDA and/or EMA quality and regulatory processes. Prior experience with regulatory filings is highly desired
· Experience working with external partners is highly desirable
· Experience actively participating in a steering committee or joint development committee for pharmaceutical, biotech, or medical device product development is highly desired
· Ability to work independently in decision-making and resolution of program obstacles and conflicts
· Familiarity with developing budgets and forecasting is desirable
· Keen insight, independent judgment and tactful discretion are required
· Must be able to demonstrate strong analytical and problem-solving capabilities
· Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture”
· Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required.
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
Turnstone’s T cell therapy technology is based on a Selected-TIL process that revolutionizes the generation of tumour targeted T cells for adoptive cell therapy. We are looking for a passionate and driven team player with experience in cell therapy, T cell engineering and culture, and immunologic assays to help develop these next gen T cell products for preclinical and clinical evaluation. You will work alongside senior researchers and supporting technical colleagues at our Ottawa research facility (located at Carleton University), designing and executing cell-based immunology studies following established standard operating procedures (SOPs). There will also be additional opportunities to continually refine and improve the technology and manufacturing processes for this therapy. In this role, you will have the opportunity to develop your ability to think strategically, drive fast-paced execution and mentor other team members.
Responsibilities:
-Design, execute, and manage complex in vitro and in vivo studies to understand T cell activity, function, cell state and phenotype from human and rodent tissues
-Generate quality data and study summary reports in a timely manner and communicate findings to senior research staff and program teams.
-Write and review SOPs and oversee training of team members
-Contribute to a team-centric culture that embraces scientific excellence, collaboration, hard-work and continuous personal and scientific development.
Experience and Qualifications:
– Ph.D. or M.Sc. (with research focused primarily in immunology) AND post graduate experience or biotech/pharmaceutical industry experience.
-Robust understanding of innate and adaptive immune systems and expert knowledge of immune based in vitro assays, flow cytometry, cell-based and biochemical assays such as ICS, ELISpot and ELISA is required.
– Knowledge and experience in T cell function/differentiation/signaling/regulation, metabolism/phenotypic analysis of inhibitory and co-stimulatory targets and pathways and/or neoantigen biology and vaccines.
– Relevant knowledge and experience with pre-clinical models for adoptive cell therapy is highly preferred
-Experience with T cell engineering highly preferred
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding are what we call ‘another day at Turnstone’? At Turnstone, the science drives decision making, and our drugs are designed with the patient in mind. Like the disease we’re fighting, our platform is complex, and transformative. If you’re a passionate person, and our science excites you – this opportunity may be for you.
Responsibilities include: working as part of a team at Turnstone’s Ottawa lab located at Carleton University, running established complex analytics to support product characterization, preclinical study sample testing, and analytical development.
The Research Technician will work with senior researchers to execute of cell-based virology and immunology assays following established laboratory standard operating procedures (SOPs) as well as to assist in preparation of data/figures in support of multiple projects. Additional responsibilities will include inventory management; organize freezers; routine maintenance; calibration and troubleshooting on laboratory equipment. We have an open, transparent and dynamic culture that embraces scientific excellence, integrity, urgency, partnerships with key stakeholders and continuous learning/improvements.
Experience & Qualifications:
This role is best suited for an analyst early in their career, looking for a development opportunity, and with the following experience:
o MSc or BSc with relevant experience in an academic or industrial laboratory
o Preferred Experience with:
Mammalian cell-culture and experience with viruses or other BSL-2 agents is preferrable
Preclinical mouse models including syngeneic and xenograft tumour models used to evaluate cancer immunotherapies and combination therapies
Recombinant DNA cloning
Protein analysis by gel electrophoresis and blotting
DNA analysis by qPCR
Biochemical assays including ELISA and cell-based reporter assays
o Ability to multi-task
o Must have good analytical and problem-solving abilities
o Self-starter with a strong work ethic and attention to detail
o Knowledge and experience with standard software (e.g. Microsoft Office Suite, Graphpad Prism)
Experience with electronic lab notebooks (ELN) would be an asset.
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
Reporting to the Virus Team Lead, the position of Research Associate-Virologist is responsible for the generation of novel oncolytic vaccine constructs to contribute to Turnstone Biologics growing pre-clinical pipeline. Principal duties include experimental work (construct design, viral rescue, virus production, and characterization), literature searches, presentations and general laboratory duties. The candidate will demonstrate their ability to participate in a highly matrixed and innovative research environment with a track record of translating basic research findings into novel therapeutic strategies that support clinical drug development. The position contributes as part of a multidisciplinary team with the development of strong cross-functional relationships being important for success.
Responsibilities:
• Execute experiments following direction from Virus Team Lead
• Perform various experimental methods such as:
o Recombinant DNA cloning
o Virus engineering and rescue
o Cell based assays, tissue culture, flow cytometry, immunofluorescence
o Protein analysis by gel electrophoresis and blotting
o ELISA
• Ability to multi-task and conduct multiple experiments concurrently
• Ensure research studies are completed at a high quality in the determined timeframe
• Attention to detail demonstrated through comprehensive records in laboratory notebooks
• Report generation on completed studies
• Assist with regulatory document preparation as required
• Other assigned duties and responsibilities as required.
Experience & Qualifications:
MSc in virology, molecular biology, or a related field or a BSc with relevant experience
• Experience with molecular biology and viral engineering is an asset.
• Excellent communication skills, both verbal and written are required.
• Ability to work both independently and collaboratively in a cross functional team (with internal teams/academics/industry collaborators).
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
The Director of Program Management will design appropriate program management plans and processes to support clear communication, decision making, prioritization and resource planning. Interact collaboratively with colleagues to ensure alignment on project action items, deliverables, and vision. Responsible for planning and execution of product development projects in the RIVAL portfolio. Plans and directs schedules and monitors budget/spending. Ensures consistent practices throughout all phases of the project life cycle. Drives the development and manages the execution of high quality, integrated cross-functional plans for projects. Applies project management best practices in the development, initiation, planning, execution, control and closing of projects. Provides clear direction on product development requirements to meet expectations of internal and external stakeholders. Interacts with research and development, manufacturing, clinical and regulatory departments and with external stakeholders. Responsible for project performance, risk management, administration, financial management and issue resolution for functional group.
• Ensuring that programs in the Research and Development portfolios are supported with appropriate and consistent Project/Program Management support, including:
o Facilitating the development of cross functional strategy and ensuring appropriate communication to internal stakeholders
o Defining program level plans that include scope, timelines, milestones, deliverables, key Go/NoGo decisions points, resources, and budgets
o Tracking and owning program timeline, milestone, and budget data
o Leading the team through planning for cross functional transitions
o Ensuring that changes to program timelines are appropriately communicated to the team and Leadership
o Coordinating team meetings as needed to meet team deliverables, track decisions and follow up on action items
o Working with the team to identify program risks and develop mitigation strategies
o Partnering with Program Team Leader to drive the team to clear and effective decision points.
• Ensuring that corporate alliances and/or academic collaborations are supported with Alliance management support, including:
o Facilitating joint team meetings at appropriate frequency to meet the needs of the team
o Ensuring internal team and leadership team is aware of and working towards meeting collaboration expectations
o Understanding Turnstone positions on strategic goals and ensuring appropriate communication to partner
o Ensuring team is meeting contractual obligations and flagging to leadership when contractual interpretation is required
• Maintaining close cross-departmental relationships to ensure that all critical parties are aware of project activities, issues and contingencies.
• Proactively, and independently, identifies and resolves program team challenges.
• Preparing information with appropriate input from program team members for internal as well as external partner review/governance meetings
• Developing and implementing communication tools that enhance information exchange within program teams and across functions
• Serving as an integral member of the program management function, ensuring cross-functional alignment of program strategies.
• Driving high performing, cross-functional teams to promote effective communication and ensure integration and alignment of internal subject matter experts via team meetings and program updates
• Performing effective risk management assessments with the Program Team, the Program Leader, and stakeholders
• Reviews and proposes revised program work plans to accommodate changes in technical, marketing, or business objectives
• Providing input along with other senior managers in establishment of strategic plans and objectives. Accountable for making final decisions on administrative or operational matters and ensuring operations effective achievement of objectives.
• Partnering with functional leaders to define project strategies and proactively identify and escalate risks, gaps and challenges, key dependencies and decisions points. Works with teams to develop scenarios and solve problems
• Tailoring program, approach and systems to small and rapidly growing organization.
Experience & Qualifications:
In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size and growth, we will give you plenty of opportunities for you to be an inspirational and collaborative co-functional leader. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!
We are in the early stages of building strategies, structures and process so this role will be busy and expanding. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.
Requirements:
• MSc or BSc Degree
• 8+ years experience in a project management role in a biotechnology or pharmaceutical company
• PMP Project Management Certificate preferred
• Experience with advanced therapeutics including virus- and cell-based therapies preferred
• Oncology experience is highly desirable
• Familiar with drug development process and a demonstrated understanding of the clinical development process
• Ability to foster business relationships with internal and external business partners.
• Proven ability to influence others to get things done without formal authority.
• Demonstrated ability to map out new business processes and improve existing processes
• Ability to facilitate, negotiate and communicate in cross-functional team environment to achieve overall project goals.
• Self-motivated, comfortable in fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Effective communication, interpersonal skills, collaboration and negotiation skills
• Highly organized and efficient, close attention to details and able to orchestrate multiple projects simultaneously
• Able to represent and communicate project timelines/priorities at senior management meetings
• Proficiency in using Microsoft Office suite – Word, Excel, PowerPoint and Project.
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
This role is part of the Computational Sciences team parting with the Translational Medicine Biomarker team to build and utilize big-data platforms to analyze preclinical, translational, and clinical data. This is a hands-on technical role in which you will aggregate patient clinical data and biomarker data (bulk and single cell NGS and TCRseq, multiplexed flow cytometry, pathology, functional immunology, and proteomic data) to assist in the identification of relevant biomarkers as well as to generate hypotheses that will define and drive the next generation of oncology therapies.
The responsibilities for this role include:
– Manage and evolve global data platforms for clinical and multidimensional correlative data and integrate and analyze such data to understand and define predictive biomarkers, mechanisms of action, mechanism of resistance and disease selection so to drive our optimal clinical development as well as discovery efforts.
– Design and implement computational bioinformatic methodologies to analyze and interpret data from a wide variety of sources including clinical data, external literature, high throughput genomic data, multidimensional pathology data, flow cytometry, functional immune and proteomic data.
– Utilize APIs, data exploration and visualization tools as well as bioinformatics approaches to support discovery, pre-clinical and clinical studies including, but not limited to, informing new disease indications for our therapies, and developing predictive biomarkers
– Collaborate with domain experts in privacy, security, and compliance to ensure that the R&D data platforms uphold privacy, security, and compliance requirements
Experience & Qualifications:
– PhD or Master’s degree in bioinformatics, computer science, statistics, data science or a related field with a particular focus on data analysis.
– This role will be positioned out of either site in San Diego or Ottawa
– Willingness to travel (when it’s safe as it pertains to global pandemics) up to 10-30% to other Turnstone sites and/or external CMOs throughout North America (USA, Canada) and Europe
– First-hand experience using patient clinical and biomarker data (proteomic, flow cytometry, pathology and genomic data-bulk and single cell NGS) in concert with preclinical and public NGS data to develop and support disease selection and biomarker strategies
– 5 years of experience in life sciences, pharma or informatics industry working with clinical trials data, genomics, and biomarker data is preferred.
– 5 years of hands-on experience of applying data science methods and tools to diverse problems using R and/or Python is preferred.
– Expert programmer in at least one language, with experience working in production environments.
– Experience with statistical analysis, bioinformatics/genomics tools (such as GATK, BEDtools, VCFtools, STAR aligner, DEseq, etc.) and databases
– Experience with existing and upcoming statistical methods (supervised and unsupervised) in pharmaceutical data analysis
– Proven ability to work in a matrix environment is preferred
– Comfortable in a dynamic environment with competing priorities
– Strong communication both written and spoken
– Strong interpersonal skills and a communication style that matches the Turnstone style: respectful, transparent, and constant
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
In this role, you will have the opportunity to develop your ability to think strategically and drive fast-paced execution. With our company size and growth, we will give you plenty of opportunities for you to be an inspirational and collaborative functional leader. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!
This role will lead the development of data platforms to analyze preclinical, manufacturing and clinical data. You will lead the aggregation and analysis of multiple data types including bulk and single cell genome and transcript sequence data, multiplexed flow cytometry, proteomics, pathology, functional immunology, and manufacturing data. You will help define mechanisms of action, manufacturing optimization strategies and product portfolio development and selection as well as to generate hypotheses that will define and drive the next generation of oncology therapies.
We are in the early stages of building strategies, structures and process so this role will be busy and expanding. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company. Turnstone is based in Ottawa, Canada, and San Deigo, USA. This role can be associated with either site, or remote, assuming flexibility to travel between sites as required.
The Responsibilities of the role include:
• Supervise and mentor all company bioinformatics/computational biology/machine learning staff to generate biological insights.
• Lead end-to-end analyses that include tool development, processing, analysis, iteration with partners, and presentation of results
• Design, execute, and own computationally efficient software solutions to analyze large, complex genomics datasets using machine learning and statistical methods
• Investigate the biology of tumor-reactive T cells, nucleic acid in cancer, generate statistically secure findings, and relate them to performance and clinical value of novel gene and cellular therapies
• Interact cross-functionally and work closely with interdisciplinary teams including research, clinical, product development, laboratory operations, and external collaborators
• Lead cross-functional collaborations between informatics team and other R&D and GMP manufacturing functions and teams
• Work with company executive leadership to formulate and translate corporate strategy and priorities into concrete informatics projects and deliverables
• Represent company externally in informatics in business development activities and industry conferences
• Stay abreast of industry and academic developments in the statistical genomics and real-world evidence generation and apply to translational study design and analysis
Requirements
• Ph.D. (or MSc + with at least 8 years) in Bioinformatics, Computational Biology, Statistics, Biological Sciences, Cancer Biology, Genetics, Genomics, Computer Science, Physics, or equivalent preparation and experience.
• This role will be positioned out of either site in San Diego or Ottawa
• Willingness to travel (when it’s safe as it pertains to global pandemics) up to 25% to other Turnstone sites
• Proven track record of strong contributions demonstrated by highly cited publications, impactful tools, products, or data sets used by the scientific community and presentations at international conferences.
• Track record of significant scientific contribution to successful drug or diagnostic development programs
• Deep expertise in cancer genomics
• Extensive experience in molecular biology and NGS assay development and automation
• Experience with Illumina NGS workflows including library construction, hybrid capture enrichment, or amplicon-based sequencing
• Lead authorship roles on high-impact publications
• Experience with commercial deployment of AWS services and scale up/out of genomics analysis.
• Experience leading informatics in the FDA regulated / GMP manufacturing setting
• Able to work effectively in a fast-paced, small biotech environment
• Strategic agility and strong critical and logical thinking
• Willingness to roll-up sleeves and pitch in to help team hit milestones
• Strong ability to prioritize, multi-task, and work in an evolving environment
• Excellent presentation and written/verbal communication skills
• Contribute to building a culture that embraces scientific excellence, integrity, urgency, partnerships with key stakeholders and continuous learning/improvements.
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
This role will build and utilize big-data platforms to analyze preclinical, manufacturing and clinical data. This is a hands-on technical role in which you will aggregate and analyze multiple data types including bulk and single cell genome and transcript sequence data, multiplexed flow cytometry, proteomics, pathology, functional immunology, and manufacturing data. You will help define mechanisms of action, manufacturing optimization strategies and product portfolio development and selection as well as to generate hypotheses that will define and drive the next generation of oncology therapies.
We are in the early stages of building strategies, structures and process so this role will be busy and expanding. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.
The responsibilities of this role include:
• Model and analyze large, complex genomics datasets using machine learning and statistical methods to generate biological insights
• Support cross-functional collaborations between informatics team and other R&D and GMP manufacturing functions and teams
• Create and/or operate computational approaches and analytical tools or customize existing applications (as required) to interrogate immune cell quantity, function and phenotype within the tumor microenvironment
• Investigate the biology of tumor-reactive T cells, nucleic acid in cancer, generate statistically secure findings, and relate them to performance and clinical value of novel gene and cellular therapies
• Consult within research and cross-functionally to analyze problems, recommend informatics-based solutions, or determine computational strategies.
• Work closely with interdisciplinary teams including research, clinical, product development, laboratory operations, and external collaborators
• Represent company externally in informatics and industry conferences
• Stay abreast of industry and academic developments in biological computational science
• Generate, interpret and communicate knowledge from gene expression profiles, genome annotation, TCR sequencing and single cell RNA sequencing data
• Manipulate publicly accessible, commercial, or proprietary genomic, proteomic, or post-genomic databases.
• Improve user interfaces to bioinformatics software and databases.
• Instruct others in the selection and use of optimal and appropriate bioinformatics tools
• Review professional literature to maintain professional knowledge.
• Contribute to building a culture that embraces scientific excellence, integrity, urgency, partnerships with key stakeholders and continuous learning/improvements.
Requirements
• Ph.D. (or MSc + at least 3 years) in Bioinformatics, Computational Biology, Statistics, Biological Sciences, Cancer Biology, Genetics, Genomics, Computer Science, Physics, or equivalent preparation and experience.
• This role will be positioned out of either site in San Diego or Ottawa
• Willingness to travel (when it’s safe as it pertains to global pandemics) up to 25% to other Turnstone sites
• Proven track record of strong contributions demonstrated by highly cited publications, impactful tools, products, or data sets used by the scientific community, presentations at international conferences, and awards.
• Deep expertise in cancer genomics
• Track record of scientific contributions to successful drug or diagnostic development programs
• Experience with NGS software workflows and analysis of single cell, whole exome, or targeted NGS sequencing data (DNA and RNA) on Illumina HiSeq/MiSeq sequencers
• Experience with Illumina NGS workflows including library construction, hybrid capture enrichment, or amplicon-based sequencing
• Experience working in the cloud (AWS), on a Linux based high-performance computing cluster, and contributing to shared code bases is desirable
• Proficiency with statistical analysis in R or Python, and data visualization highly desirable
• Experience with ELN and LIMS systems is desirable
• Working knowledge of single cell genomics analysis is preferred
• Lead authorship roles on high-impact publications is desirable
• Experience in supporting informatics in the FDA regulated / GMP manufacturing setting is desirable
• Working understanding of innate and adaptive immune systems is preferred
• Able to work effectively in a fast-paced, small biotech environment
• Willingness to roll-up sleeves and pitch in to help team hit milestones
• Strong ability to prioritize, multi-task, and work in an evolving environment
• Excellent presentation and written / verbal communication skills
• Strong interpersonal skills and a communication style that matches the Turnstone style: respectful, transparent, and constant
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
The Research Associate or Senior Associate, in this individual contributor, lab-based role, will work in a collaborative environment to perform Analytical testing and development to support Turnstone’s TIL cell therapy development programs. This position will join the development group and work with the analytical testing group that values data quality, high productivity and teamwork. The key deliverables for this role are precise, accurate, and high-quality data presented, communicated, and integrated in an effective manner. This position will require thorough documentation of all experimental steps and final data readout.
Responsibilities:
• Execution of key analytical methods such as multi-parameter flow cytometry, bioassays and qPCR-based methods and data analysis in support of process development activities, product characterization, and raw materials testing.
• Provide support to other groups for assay development, qualification, and transfer into Analytical Development
• Developing processes and methods to improve lab execution and data analysis
• Timely and thorough documentation and completion of electronic laboratory notebooks
• Author reports detailing experimental work and summarizing results
• Contribute to an overall high-performing laboratory, with a willingness to contribute in all ways, such as ordering, tracking, and maintaining inventory of lab supplies and reagents
Experience & Qualifications:
• BS in a scientific discipline 2+ yrs experience (1+yrs with MS) of relevant industrial experience. Final role can be commensurate with relevant industry experience.
• Experience with flow cytometry or cell-based bioassays, ELISA, and PCR techniques
• Experience with aseptic cell culture and cell-based assays.
• Ability to follow laboratory procedures with attention to detail, and successfully execute experiments at the bench.
• Experience with other techniques in molecular biology, such as RT-PCR is preferred
• Previous experience with cell therapy products is preferred
• Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment
• Working knowledge of statistical software (R, JMP, Minitab) is preferred.
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
As an Engineer or Sr. Engineer (depending on your relevant experiences and expertise), you will provide process development and engineering support for process design, characterization, and improvements with a goal of ultimately enabling GMP manufacturing. Primary responsibility will be to design, lead, and execute experiments that contribute to development and characterization of the TIL cell therapy manufacturing process. Experiments will be performed to identify and define Critical Process Parameters and process ranges. Additionally, you will draft and review study plans and reports, analyze and trend process data, perform Design of Experiments (DoEs), and provide technical support for manufacturing sciences, technology, and process changes. Turnstone works in a highly cross-functional environment, so your contributions will be critical for our pre-clinical, clinical, and regulatory workflows, with an opportunity to engage and enable your colleagues across the business.
Responsibilities:
• Develop manufacturing processes for cell therapy products and develop process improvements and efficiencies
• Lead and execute laboratory studies to support process design and development, characterization and process improvements
• Write and review technical documentation
• Participate and report to a cross-functional development team to advance production activities
• Assist in technology transfer to GMP manufacturing by generating development reports and providing on-site technical support.
• Authoring and assistance in the technical review of supporting documents, reports, including CMC sections for regulatory filings.
• This is a hands-on position requiring conducting laboratory experiments, good documentation review skills, good writing skills, and the flexibility to move between the management and execution of each required function as needed.
• Act as technical expert to train and supervise process technicians
Experience & Qualifications:
• Minimum of 3 years of relevant industry experience, with role flexibility available commensurate with experience
• Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical/biotech manufacturing & process development experience required
• Fluency with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
• Cell culture and aseptic processing experience
• Working knowledge of scientific and engineering principles
• Experience in statistical analysis using JMP or Minitab
• Practical experience in GMP operations
• Ability to function efficiently and independently in a changing environment
• Self-motivated and willing to accept temporary responsibilities outside of initial job description
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• The primary location of the position is San Diego, but may be required to travel, based on business priorities
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size and growth, we will give you plenty of opportunities for you to be an inspirational and collaborative co-functional leader. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!
We are in the early stages of building strategies, structures and process so this role will be busy and expanding. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.
Our Virus Manufacturing (VMFG) team is growing. As part of the Technical Operations organization, the VMFG team is responsible for the GMP manufacture of Cell Banks, Virus Banks, Drug Substance and Drug Product for our clinical-stage assets. VMFG supports technology transfers and collaborates closely with the Virus Development & Manufacturing Sciences team to develop and capture process knowledge and ensure overall manufacturing success. As an Associate Engineer of Virus Manufacturing on the VMFG team, you will be tasked with supporting manufacturing campaigns from end-to-end within our external contract manufacturing organization (CMO) network.
The responsibilities for this position span across our multi-modal platform and include:
– Support virus manufacturing campaigns with external CMO partners
– Support virus manufacturing batch readiness including process definition, raw material procurement, and batch documentation preparation
– Support ongoing batch monitoring including person-in-plant coverage
– Support cross functional teams troubleshooting and resolving issues with ongoing manufacturing runs
– Support virus manufacturing campaign closeout including the review of executed batch records and shipping/logistics of finished material
– Support process development, engineering runs, and other process scale-up related studies
– Support the identification and selection of new external CMO partners
– Support drafting of regulatory documentation including INDs, CTAs, etc.
– Represent the Virus MFG team at Technical Operations cross-functional program meetings
Experience & Qualifications:
• This Associate Engineer role will be formally positioned out of our Ottawa, Canada office
• Willingness to travel (when it’s safe as it pertains to global pandemic) up to 10-30% to other Turnstone sites and/or external CMOs throughout North America (USA, Canada) and Europe
• BSc in a science, engineering, or biotechnology related discipline; MSc considered an asset
• 1-3 years’ experience in a technical operations or research/development role
• Experience with live virus based therapeutic manufacturing such as viral immunotherapies, vaccines, cell and gene therapies, or other complex biologics
• Experience with good manufacturing practices (GMP) in a clinical or commercial manufacturing setting
• Experience with the qualification and operational use of single use, small scale mammalian cell culture, tangential flow filtration, and/or chromatography-based purification equipment and raw materials
• Comfortable in a dynamic environment with competing priorities
• Strong technical writing skills
• Teamwork – willingness to lead and willingness to be lead when it’s appropriate
• Positive Attitude – interest in learning how to adapt to fast-growing teams and a dynamic virtual working environment
• Communication – interest in learning how to communicate effectively cross functionally with multiple levels in the organization and externally to global partners
• Growth mindset – constant approach of challenging oneself to learn more, learn faster, and learn better
• Excellent computer skills, including Microsoft Excel and PowerPoint
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
The Manager (or Sr Manager), Supply Planning will be responsible for investigational product (IP) supply for a clinical development program which is rapidly maturing and expanding to multiple global jurisdictions. The intent of the role is to start with a focus on our active early phase viral immunotherapy clinical studies, with potential opportunities to support other product modalities and product intermediates.
The responsibilities for this position include but are not limited to:
– Lead the integration of the clinical development plan and the manufacturing plan to create an actionable, end-to-end, long range strategic supply plan
– Lead the constant iterative re-modeling of supply plan scenarios to help inform program-level and functional-level decision-making across clinical development and technical operations
– Lead manufacturing campaigns at label-and-pack contract manufacturing organization (CMO) partners to create finished goods (FG/IP) ready for clinical distribution
– Partner with Regulatory Affairs and Clinical Operations to develop and manage IP and ancillary product labels for multiple jurisdictions
– Lead selection, strategic integration, and activation, and ongoing operation of clinical supply depots for IP, ancillary supplies, and other stored materials required for global clinical trials
– Monitor clinical IP supplies at sites and depots and provide supply metrics to support clinical operations needs around the globe
– Lead relationship management of label-and-pack CMO partners and the evaluation and selection of new CMO partners
– Lead GMP inventory management, including the tracking of actual inventory, as well as driving development of the tools, systems, and naming conventions utilized to enable efficiency and compliance
– Serve as a key stakeholder in the Technical Operations and Clinical Operations interface, including leading cross-functional meetings and teams to achieve integration of workstreams (production planning, testing planning, clinical operations, etc.)
Experience & Qualifications:
This Manager (or Sr Manager) role will be formally positioned out of our San Diego, CA office but working from home/remotely will be a part of the normal work routine
– Willingness to travel (during normal times) up to 10-20% to other Turnstones sites and/or external CMOs throughout North America (USA, Canada) and Europe
– BS degree in a relevant life sciences, engineering, or business management discipline
– 5-8 years’ experience in a clinical supply chain management across early to late phases of clinical development and multiple jurisdiction (Europe, Asia-Pacific, North America)
– 3-5 years’ experience in a team and/or cross-functional leadership role
– Strong understanding of and experience with GMP and GCP requirements
– Experience with implementation and operations of ERP (Oracle, SAP or NetSuite) and Interactive Response Technology (IRT) systems
– Experience working with and managing multiple third-party/external partners
– Experience with global clinical trials, ultralow cold chain, and sourcing of comparator IMPs highly preferred
– Excellent Excel abilities required
– Teamwork – willingness to lead and willingness to be lead when it’s appropriate
– Positive Attitude – ability to adapt to fast-growing teams and a dynamic virtual working environment
– Communication – must be able to communicate effectively cross functionally with multiple levels in the organization and externally to global partners
– Growth mindset – constant approach of challenging oneself to learn more, learn faster, and learn better
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision-making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
The Analytical Life Cycle Management team is growing quickly and establishing workflows and practices to ensure analytical excellence of the QC test methods that are used for all stages of product manufacturing and GMP release and characterization of Turnstone’s novel biotherapeutics. Reporting into the Technical Operations department, this team is responsible for life-cycle management of current and future analytical methods and alignment with applicable policies and regulatory requirements. To support this goal, the team is responsible and accountable for continuous test method improvement activities, for enabling innovation, and for introduction of new technologies. The team works closely with Quality Control and contract testing organizations, overseeing qualification, and examining method performance and trending to support ongoing method optimization and improvements. As the Scientist of the ALCM team, you will report to the Associate Director of ALCM.
In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size and growth, we will give you plenty of opportunities for you to be an inspirational and collaborative leader. Passionate about being a part of a critical function of a growing company and continuous learning? You will be engaged in a team and a workflow that plays a critical role in getting cutting edge therapies to people suffering from cancer.
We are in the early stages of building strategies, structures, and processes so this role will be busy and expanding. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.
Position Responsibilities:
· This role will be formally positioned out of Ottawa, Canada or San Diego, California
· Extensive experience developing and troubleshooting cell-based and potency assays and ensuring that life-cycle management of analytical methods is implemented and aligned with applicable policy and regulatory requirements
· Solid experience with other analytical techniques such as Flow Cytometry, Next Generation Sequencing, etc.
· Knowledge and experience in analytical method development, method validation, and method transfers.
· Working knowledge and application of GMPs/GLPs principles, ICH guidelines and compendial methods
· Experience in Cell therapy, vaccines, or biological products
· Comfortable in a dynamic environment with competing priorities
· Strong technical writing skills
· Strong communication both written and spoken
· Strong interpersonal skills and a communication style that matches the Turnstone style: respectful, transparent, and constant
· Excellent computer skills, including Microsoft Excel and PowerPoint
· 5+ years of related experience in area of Pharmaceutical/Biologics industry
· M.Sc./Ph.D in Biological sciences or Life Sciences fields or B.Sc. with extensive industry experience.
Requirements:
· Develop Analytical Target Profiles for new and existing test methods
· Perform Lifecycle Management of Analytical Procedures: perform assessments of method validation/qualification and performance; identify gaps and required corrective actions; trend, analyze and interpret data.
· Perform analytical method development, method qualification/validation and method transfers
· Prepare and/or coordinate with contract testing organizations for analytical methods, protocols, reports and other documents related to analytical development and qualification/validation activities
· Keep up to date with scientific and technical developments
· Responsible for complex decision making, optimization and troubleshooting of methodologies
To Apply:
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
The Quality Control team is growing quickly and establishing our work flows and practices to ensure analytical and operational excellence in support of Turnstone’s novel cancer immunotherapies and cell therapy products. Reporting into the Technical Operations department, this team is responsible for the GMP testing, QC release, Shelf life Stability and QC vendor management program of our RIVAL and TIDAL products. To support this goal, the team oversees all GMP testing activities at our global network of contract testing organizations in addition to specification setting and management of inventory, cell banks, and critical reagents in accordance to regulatory and compendial requirements. The team works closely with Manufacturing, ALCM, and Contract organizations supporting product comparability, qualification, and tech transfers to GMP partners. As the Senior Scientist of the QC team, you will report to the Associate Director of QC and will have the opportunity to work with all clinical-stage assets (viral and cell therapy).
The responsibilities for this role include:
· Lead a small team of high-performing scientists, supporting them in their goals so that they can be the best versions of themselves every day, while being engaged and fulfilled. The team is small and flexible and will require a leader that is able and willing to roll up their sleeves and help in the day to day as much as build thoughtful systems supporting the team’s growth and operations.
· Manage the QC Lot release program for multiple products in early phase clinical development to meet corporate goals and clinic needs
· Perform analytical data review and provide technical expertise to support data review of viral and cell therapy-based methods for lot release, characterization, and stability testing
· Optimize and maintain a sustainable stability program management system for diverse products
· Design and develop stability testing/trending strategies to support shelf-life stability claims
· Implement systems to routinely analyze release and stability data and trends to support setting specifications, shelf life stability, organizational needs, and continuous improvement activities
· Develops and generate metrics and KPIs to capture RFT (Right First Time) supporting operational excellence initiatives
Experience
In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size and growth, we will give you plenty of opportunities for you to be an inspirational and collaborative leader. Passionate about being a part of a critical function of a growing company and continuous learning? You will be engaged in building a team and a workflow that plays a critical role in getting cutting edge therapies to people suffering from cancer.
We are in the early stages of building strategies, structures, and processes so this role will be busy and expanding. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.
· This role will be formally positioned out of Ottawa, Canada
· Strong knowledge of a complement of FDA, EMA, ICH, USP, and EP guidelines and regulations for QC and stability program implementation of biological or cell therapy products
· Experience with implementation, optimization, and management of shelf-life stability programs for novel therapeutics
· Extensive knowledge of QC analytical testing supporting biologics, vaccines, or cell therapy products e.g. cell based assays, compendial methods, flow cytometry, cell counting, ELISA, PCR. Special consideration will be given to candidates with a working knowledge of next-generation sequencing technologies
· Self-motivated, comfortable in fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
· Ability to make informed, data-driven and risk-based timely decisions
· Strong aptitude to enable trust, build authentic relationships, constructively challenge conventional thinking, influence stakeholders, lead and cooperate in a team setting, share information, and deliver results
· Experience with QC analysis and investigations applicable to for e.g. products, raw materials, EM Programs, chemistry, microbiology, and molecular biology assays
· Strong communication both written and spoken
· Strong interpersonal skills and a communication style that matches the Turnstone style: respectful, transparent, and constant
· Excellent computer skills, including Microsoft Excel and statistical software such as JMP
· 8+ years of related experience in area of Pharmaceutical/Biologics industry
· M.Sc./Ph.D in Biological sciences or Life Sciences fields or B.Sc. with extensive industry experience.
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding are what we call ‘another Thursday at Turnstone’? At Turnstone, the science drives decision making, and our drugs are designed with the patient in mind. Like the disease we’re fighting, our platform is complex, and transformative. If you’re a passionate person, and our science excites you – this opportunity may be for you.
Responsibilities include: working as part of a team at Turnstone’s Ottawa lab, running established complex analytics to support product characterization, preclinical study sample testing, and analytical development.
Experience and qualifications:
This role is best suited for an analyst early in their career, looking for a development opportunity, and with the following experience:
· 2+ years of hands-on experience in the lab (school lab experience counts) performing several methods such as:
o virological and cellular assays (tissue culture, plaque assay, killing assay, TCID50, infections, etc)
o molecular assays (qPCR, PCR, Bradford, ELISAs, Western blot, etc)
· Education: diploma or degree in biochemistry, biotechnology, or relevant field
· Agile in a lab setting, able to quickly learn established methods
· Experience following a procedure several times to generate precise and accurate results
· Careful and diligent method execution and reporting
· Organized and able to manage time to enable the execution of several experiments at once when required
· Very comfortable using Microsoft applications (Excel, Word, PowerPoint). Experience with analytical software such as JMP would be an asset.
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding are what we call ‘another day at Turnstone’? At Turnstone, the science drives decision making, and our therapies are designed with the patient in mind. Like the disease we’re fighting, our platform is complex, and transformative. If you’re a passionate person, and our science excites you – this opportunity may be for you.
If you are interested in being a part of a growing Regulatory Affairs and Quality Assurance team, then this role may be for you! As the Technical Coordinator, Quality Assurance, Reporting to the Head of Quality you will support the team to establish and implement the quality systems which enable GXP compliance in accordance with country regulations and guidelines, as well as the company’s policies and procedures. The focus will be on GMP activities, with strong interfaces to the technical operations team, the clinical operations team (GCP) and the pre-clinical/R&D team (GLP).
The responsibilities and critical expectations include the following:
• Work within the electronic document management system to support the development of GXP templates, review and approval of SOPs, Forms, Specifications, Master Production Records, Protocols and Reports and other related GMP records
• Coordinate Administration and provide User/Training Support for electronic Quality Management Systems (QMS)
• Assist in development and maintenance of GXP policies and procedures and support the monitoring of its performance
• Support the management of activities related to archival of GXP documents and samples, including scanning where applicable, cataloging, filing, and coordinate shipment of records to and from offsite storage facilities
• Support the management of department/employee training programs and plans
• Coordinate a centralized system for issuance and tracking of GMP document numbers, batch lot numbers, deviation and change control numbers
• Support the management and status tracking of Quality Agreements and Audits including schedules, reports and CAPAs
• Support the design and implement databases as required by Quality Assurance team members
• Support the coordination of QA driven communication, presentations and workshops
• Prepare reports for management review
What’s in it for you?
In this role, you will have the opportunity to develop your ability to build processes and drive these to implementation. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!
Experience:
This role is best suited for someone with the following:
• College Diploma required, Bachelors degree in Science preferred
• Minimum of 2+ years of experience in QA or in a related field
• Knowledge of documentation control requirements to meet FDA/Health Canada regulations
• Fundamental training in GMP (preferred)
• Experience with Microsoft Computer Products (Word, Excel, Access, PowerPoint). Experience with Document management or QMS etools (Veeva, TrackWise, ShareFile,Egnyte or equivalent)
• Demonstrated ability to manage multiple projects and variable workloads with demanding timelines.
• Strong interpersonal, teamwork, and organizational skills; effective oral and written communication skills.
• The candidate must exude a mature communication style that matches the Turnstone style: respectful, transparent, with a high degree of integrity and humility
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Position Overview:
Reporting to the Vice President, Clinical Operations, the Clinical Project Manager (CPM) is responsible for the overall management and execution of operational activities involved in the planning, implementation, conduct and completion of clinical trials. This includes management of study deliverables, adherence to budget and timelines, negotiating vendor agreements, approving vendor and Investigator invoices and accruals, and ongoing risk mitigation. The CPM leads and engages with cross functional study teams and stakeholders (program management, site education and monitoring, clinical science, data management, biostatistics, medical writing, medical affairs, regulatory affairs, clinical accounting, and clinical QA) to ensure the project is completed on time, within budget, and with high quality.
Responsibilities:
· Manage and coordinate all aspects of assigned global clinical trials to ensure they are conducted in accordance with established protocols, Company standards (SOPs), ICH/GCP and applicable jurisdiction regulations.
· Identify and manage the identification, evaluation, and selection of external vendors (central lab, CROs, consultants/contractors, etc.) from RFP through budget/ contract negotiations and execution.
· Performs ongoing vendor management to ensure deliverables, high performance standards, and adherence to the contract or change order
· Oversees, manages and reports on project activities, including scope, schedule, budget and risk associated with each assigned project.
· Identifies and tracks key study metrics in order to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed)
· Develops clinical trial timelines and operational budget, tracks the overall study critical path and manages/oversees all study activities to ensure on-time study delivery.
· Reports study performance and timelines to senior management
· Assists in the identification, selection and initiation of clinical sites
· Oversees the development of required study plans and execution of those plans related to site monitoring, safety management, data management and biostatistics
· Oversees development of CRFs and clinical and safety databases
· Plans, coordinates and conducts investigator meetings globally
· Plans, coordinates and conducts Data Safety Monitoring Board (DSMB) meetings
· With Medical Affairs, assesses trends in data including adverse events, protocol violations, etc.
· Coordinates and manages timely database freeze and database lock.
· Participates in data review meeting.
· Ensures eTMF maintenance in accordance with regulatory standards and requirements
· Assists the scientific staff in developing and reviewing protocols, investigator brochures, informed consent forms, clinical study reports and other scientific documents
· Assists Regulatory Affairs as necessary for IND/CTA filing and other necessary compliance requirements.
· Ensures that clinical operations milestones are prioritized and that team members remain on task to achieve business and departmental goals
· Leads clinical operations meetings with vendors, interdepartmental staff, and alliances.
Experience & Qualifications:
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Qualifications:
BS in scientific discipline or pharmacy, RN, or BSN degree or equivalent combination of education and experience
Minimum 2 years of clinical trial/project management experience. Prior experience as a CRA or on-site is preferred, as well
Oncology experience required
Oncolytic virus, cell therapy, or immunotherapy experience is preferred.
Ability to travel internationally or domestically up to 10-20% based on study demands
Excellent working knowledge of GCP/ICH Guidelines
Ability to work effectively independently or as part of a team, remotely or in-office
Comfortable managing multiple projects and ability to adapt to changing priorities
Effective written communication skills and computer skills are required
Strong understanding of Clinical Development
Self-starter and able to “wear many hats” while communicating with a cross-function team in a mid-sized biotech.
To Apply:
Please click here to apply!
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Contact
New York City
920 Broadway, 16th Floor,
New York, NY 10010, US
(347) 897-5988
Ottawa
12 York Street, 3rd Floor,
Ottawa, ON K1N 5S6, CA
(613) 421-8930
San Diego
Center for Novel Therapeutics
9310 Athena Circle
La Jolla, CA 92037, US
(347) 897-5988