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.
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.
Venkat Ramanan, PhD
Chief Financial Officer
Dr. Ramanan brings more than 20 years of experience in the biopharmaceutical industry. He was most recently at Seagen where in his role as Senior Vice President of Finance, he led the finance function through a transformational period as the company launched several products, expanded its global footprint and executed multiple strategic transactions. Prior to Seagen, Dr. Ramanan worked in positions of increasing responsibility in finance, supply chain planning and commercial operations at Gilead Sciences and Amgen. Dr. Ramanan began his career in the biopharmaceutical industry as a consultant with ZS Associates. He obtained his Ph.D. in Engineering Mechanics from The Ohio State University.
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.
Adina Pelusio
SVP, 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.
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.
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.
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 Chairman and Managing Director of Versant. He is the leader of the firm, architect of its strategy, and oversees operations across North America and Europe.
Brad combines 13 years of global pharmaceutical industry leadership experience and 18 years as a venture capitalist. His track record consists of a multitude of successful investments including Amira, Okairos, Speedel, Quanticel, Novira, Flexion, Crispr, BioTie, Jecure, BlueRock, Black Diamond, Northern Biologics, Monte Rosa and the firm’s Discovery Engines that have collectively generated close to $1.7 billion in returns for Versant stakeholders. Over his tenure, he has translated that experience into building and developing the current Versant investment team.
Prior to joining Versant, Brad served as Executive Vice President, Global Head of Business Development, Licensing & Alliances at Roche, one of the largest pharmaceutical companies worldwide. Under his leadership, Roche established partnerships with over 75 venture-backed biotech companies across North America, Europe and Asia, and transformed its R&D pipeline into an industry leader. Prior to that, he held executive roles at Eli Lilly in drug discovery, clinical research, regulatory affairs and business development. Brad 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 2022.
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 an experienced and motivated Associate Scientist to join our team of immunologists driving the development of next gen TIL therapies for the treatment of cancer. The successful candidate will drive various aspects of in vitro studies by designing and executing experiments, analyzing data and presenting results in a collaborative team setting. This is an exciting opportunity to work alongside 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 tumor 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 alongside senior researchers and supporting 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.
Passionate about being a part of a critical function of a growing company and continuous learning? This could be the opportunity for you! In this role, you will have the opportunity to develop your ability to think strategically and drive fast-paced execution as part of a matrixed team. With our company size and planned growth, there will be plenty of opportunities to grow and have a strong impact across the whole research group?
We are in the early stages of building strategies, structures and processes? so this role will be busy delivering and expanding capabilities. 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 but are not limited to the following:
• Assessment of TIL functionality using in vitro assays to measure cytotoxicity, expansion, and cytokine secretion
• Molecular editing of immune cell populations and rapid expansion.
• Assessment of TIL phenotype using flow cytometry
• Coculture of TILs with tumor samples.
• The design, execution, and analysis of experiments
• Prepare data/figures to present to senior research staff
• Mentoring junior team members
• Write and review SOPs
• Contribute to a team-centric culture that values transparency, innovation, integrity, and purpose.
Experience:
• B.S, M.S or PhD in Biology with previous experience in immunology is required
• Must have extensive experience with mammalian cell culture with excellent sterile technique
• In depth experience with multi-parameter flow cytometry and phenotyping of T cell populations is preferred.
• Experience with IncuCyte and/or xCelligence platforms is preferred
• Experience with lentiviral and/or electroporation techniques for editing and engineering immune cells is a plus
• Experience with immune cell culture is required.
• Experience with cell sorting and Ella is a plus.
• Theoretical knowledge of T cell biology and a practical knowledge of T cell markers is a plus
• Strong work ethic, positive team-oriented attitude is a must
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
-T-cell sorting / human experience
-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 2022.
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 Sr. Research Technician provides support and assistance to senior researchers and project teams by performing a variety of experimental techniques using state-of-the-art instrumentation, and following established laboratory standard operating procedures (SOPs).
The candidate is expected to keep accurate experimental records and contribute to data analysis and figure preparation under supervision of senior research staff.
Additional responsibilities will include inventory management, laboratory organization, routine maintenance, and calibration of laboratory equipment.
The incumbent will participate in an innovative research environment and will support a team working to translate basic research findings into novel therapeutic strategies. The position will contribute both intellectually and experimentally to the success of a multidisciplinary team.
The responsibilities of this role include but are not limited to:
• Tissue culture: maintain primary cells and cell line cultures
• Perform multi-parameter flow cytometry
• Isolate tumor and immune cells from patient samples
• Lymphocyte expansion
• Cell based functional assays
• Perform western blots
• Keep accurate experimental records
• Autoclave instruments
• Responsible for following Standardized Operating Protocol for lab tests
• Assist in the summation or analysis of data required for communications/reports/presentations.
• Perform a range of duties associated with maintaining laboratory readiness in cooperation with other team members
• Prepare and Aliquot media and reagents
• Inventory management, i.e. order/unpack/restock/organize lab supplies as required
• Other duties as required
Experience & Qualifications:
• B.S with experience in an academic or industrial laboratory is preferred
• Experience with mammalian cell culture with excellent sterile technique is required
• Experience with flow cytometry is preferred
• Experience with immune cell culture or isolation of PBMCs is a plus
• Must have good analytical and problem solving abilities with strong attention to detail
• Knowledge and experience with standard software (e.g. LIMS, Microsoft Office Suite, GraphPad Prism, FlowJo)
• Knowledge and commitment to Occupational Health and Safety Procedures and Biosafety Procedures in a laboratory.
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 2022.
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 scientific excellence, integrity, urgency and continuous learning/improvement.
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 along side senior researchers and supporting technical colleagues at our Hamilton research facility (located at McMaster 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 explore the combination with oncolytic viral 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 and execute in vitro studies to understand T cell activity, function, cell state and phenotype from human tissues
- Perform isolation, expansion and phenotyping of various immune cell populations (T cells, DCs and B cells) for use in immounologic assays.
- Develop and execute in vitro immune assays to determine the function of genes engineered into oncolytic viruses
- 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:
- Research focused degree (Immunology preferred) 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 is preferred.
- Relevant knowledge and experience with pre-clinical models for adoptive cell therapy is highly preferred
- Experience working with oncolytic viruses in preclinical models 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:
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 along side 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 and execute in vitro studies to understand T cell activity, function, cell state and phenotype from human tissues
• Perform isolation, expansion and phenotyping of various immunce cell populations (T cells, DCs and B cells) for use in immounologic assays.
• 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 & Qualifications:
• Research focused degree (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:
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:
The CMC Development and Quality Control teams are growing quickly and establishing our work flows and practices to ensure excellence in Bioprocess and Analytic Development, as well as QC Analytics, Operations, and Compliance in support of Turnstone’s novel cancer immunotherapies and cell therapy products. This is a transversal role reporting into the Technical Operations team, spanning both development (i.e. non-GMP) and Quality Control (i.e. GMP) spaces. This role bridges gap between TechOps in support of regulatory objectives. The development team is tasked to create robust & phase-approprriate bioprocess and analytical strateiges for our RIVAL and TIDAL programs, while the the Quality Control team is responsible for the GMP testing, QC release, Shelf-life Stability, QC vendor management, and Compliance.
As the CMC Specialist/ Principal Specialist, you will report to the Associate Director of QC and will have the opportunity to work with all clinical-stage assets cross-functionally (viral and cell therapy), ensuring that TechOps meets our regulatory objectives and are supporting any regulatory submissions with appropriate documentation.
The responsibilities for this role include:
• Support the development and definition of the CMC content requirements based on regulatory and CMC strategies for timely submission of regulatory filings
• Lead cross functional collaborations to coordinate gathering of source documents, peer review of CMC content, process development and analytical method reports supporting submissions
• Write and review CMC content as well as coordinating authoring of technical & regulatory documents led by engineers and scientists within Technical Operations.
• Summarize scientific information from development reports and identify details relevant to regulatory submissions
• Evaluate data, author, and summarize reports and communicate outcomes to internal stakeholders
• Work with Regulatory to maintain risk register, CMC commitments to regulatory bodies, and monitor the completion of commitments
• Engage team by sharing risks and supporting strategy for risk mitigation
• Work with Regulatory to ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations
• Support assigned regulatory team member with compiling all CMC related submissions
• Support response strategy, assemble supporting data, draft and manage responses to CMC queries and requests for Information received from global health authorities
Requirements
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, you will have ability to create plenty of opportunities to be an inspirational and collaborative leader. Passionate about being a part of a critical function of a growing company and continuous learning? This is an opportunity to be an independent and self-directed contributor who will be responsible for converting scientific data into clear, scientifically sound, well-structured scientific, technical, and regulatory documents intended for global health authorities and internal and external stakeholders. The Technical Writer will author and manage the review and approval of CMC regulatory documents, including, technical reports, regulatory responses, source documents, and SOPs. You will be engaged in 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.
How do you know if you’re the right fit?
• You are self-motivated and love working with people. You are collaborative, optimistic, and a solution seeker
• Operational excellence and exceptional internal and external Stakeholder service are ingrained in your personality
• You have excellent comprehension of bioprocess & analytical/scientific literature, medical and scientific terminology, and statistical methods
• You have exceptional attention to details and can balance multiple activities in a complex environment, as well as meet critical deadlines.
• You can independently plan, write, and edit submission documents across multiple therapeutic areas in compliance with ICH, FDA, and global regulatory guidelines and requirements
• You have strong knowledge of a complement of FDA, EMA, ICH, USP, and EP guidelines and regulations for biological or cell therapy products
• You are comfortable with minimal direction and able to adjust workload based upon changing priorities
• You have aptitude to make informed, data-driven, and risk-based timely and strategic decisions
• You strive to enable trust, build authentic relationships, constructively challenge conventional thinking, influence stakeholders, lead and cooperate in a team setting, share information, and deliver results
• Strong communication both written and spoken
• 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
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.
What would it be like?
The Cell Therapy Manufacturing team is growing quickly and establishing our workflows and practices to ensure operational excellence. Reporting into the Technical Operations department, this team is responsible for the GMP manufacturing of our TIDAL cell therapy products: cutting-edge autologous TIL products for underserved solid cancers. This position would report to the Director of Cell Therapy Manufacturing.
What’s in it for you?
In this role, you will have the opportunity to develop your ability to think strategically, technically, and drive fast-paced execution. With our company size and growth, we will give you plenty of opportunities 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.
How do you know if you’re the right fit?
Requirements:
- This role will be formally positioned out of Ottawa, Canada or San Diego, California though consideration will be made for remote candidates in North America
- MSc or PhD in Cell Biology, Immunology, Chemical Engineering, Biomedical Engineering, or a related scientific discipline
- 5-8 years of relevant experience in a manufacturing operation, manufacturing sciences and technology, or manufacturing technical support role
- Experience managing external relationships such as CMO partners or clients as a CMO provider and a mature and thoughtful communication approach to support strong partnerships
- Independent, detailed-oriented, self-starter with excellent analytical skills with the ability to multi-task and succeed in a team environment
- Experience in statistical design and analysis
- Able to manage competing priorities effectively and adapt to changing priorities
- Ability to work independently and as part of a team
- Strong technical writing skills
- Strong communication both written and spoken
- Task & Team-oriented, analytical, organized, detail-oriented, self-motivated & ability to multi-task
- Strong interpersonal skills and a communication style that matches the Turnstone style: respectful, transparent, and constant
- Excellent computer skills, including Microsoft Excel and PowerPoint
Preferred experience:
- Experience with processing and scale-up of mammalian cells or similar and optimization of processes relevant to cell and gene therapy
- Direct experience with cell and gene therapy or regenerative medicine
- Experience with the manufacturing and operational complexity of cell therapy-based therapeutics such as TIL, CAR-T, TCR, or stem cell products is an asset
The responsibilities for this role include:
- Review of manufacturing data for trends, indications of process improvement requirements or indicators of manufacturing failure causes
- Establishing appropriate parameters for in-process testing and feedback on critical process parameters
- Batch production record review upon changes and after manufacturing
- Support in management of process deviations and assessing impact to the final product
- Person in plant
- 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:
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