ABOUT US
Our Mission
Turnstone Biologics’ mission is to deliver breakthrough viral immunotherapies to improve survival for people with cancer.
Turnstone Biologics is a privately-held immuno-oncology company with offices in New York (USA) and Ottawa (Canada). Since 2015, we have raised $50 million in venture capital financing, brought in more than $100 million in non-dilutive funding, and have received numerous biotechnology industry awards, including being named a 2017 Fierce 15 company.
Our scientific founders, Drs. John Bell, David Stojdl and Brian Lichty, are world leaders in the oncolytic virus and immunotherapy field. Collectively, they have published more than 200 publications in leading journals, and have spent years engineering and developing viruses to create the next generation of powerful, targeted therapies for cancer patients.
Our passionate team of leaders in oncology has 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
Breakthrough Viral Immunotherapies
Turnstone Biologics is developing a disruptive class of engineered viral immunotherapies, attacking cancer’s complexity with medicines designed to fight tumors at multiple points of intervention, including simultaneous generation of targeted immune responses and modulation of the tumor environment.
The Vaccinia Virus
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.
RIVAL-01 is Turnstone’s lead candidate consisting of the vaccinia virus backbone encoding three potent immunomodulators, Flt3 ligand, anti-CTLA-4 antibody, and IL-12 cytokine, specifically designed to work together to drive immune activity and re-program the microenvironment to be best suited for tumor eradication. When the vaccinia virus enters and replicates in cancer cells throughout the body, the transgenes are expressed. The resulting local production of these therapeutics at the site of tumors add to the inherent oncolytic and microenvironment modifying properties of the virus to form a powerful multi-modal attack on the disease.
our team
Leadership
Turnstone Biologics was founded by world-leading experts in oncolytic viruses and 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 viral immunotherapies based on our unique vaccinia virus platform to people with cancer.
Sammy Farah, Ph.D., M.B.A.
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.
Mike Burgess, M.B.Ch.B., Ph.D.
President, Research & Development
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.
Jane Pritchett Henderson
Chief Financial Officer
Jane Pritchett Henderson brings nearly 30 years of experience in health care and life sciences to her new role as Chief Financial Officer of Turnstone. Previously, she served as Chief Financial Officer and Senior Vice President of Corporate Development of Voyager Therapeutics since January 2017. Prior to Voyager, Ms. Henderson served as Chief Financial and Business Officer of Kolltan Pharmaceuticals, Inc., having joined the privately held biopharmaceutical company in early 2013 and leading the sale of Kolltan to Celldex Pharmaceuticals, Inc., in late 2016. Prior to Kolltan, Ms. Henderson served in various financial and business development leadership roles at ISTA Pharmaceuticals, Axerion Pharmaceuticals and Panacos Pharmaceuticals. In her more than 19 years in healthcare investment banking, Ms. Henderson executed more than 95 mergers and acquisitions, advisory and financing deals, holding senior roles at HSBC Holdings plc, Canadian Imperial Bank of Commerce, Lehman Brothers and Salomon Brothers. Ms. Henderson currently serves on the Board of Directors of Sesen Bio (formerly Eleven Biotherapeutics, Inc.) and Ophthotech as well as a non-profit foundation, The EQUUS Foundation.
José Manuel Otero, Ph.D.
Senior Vice President, Technical Operations
Dr. José Manuel (Manny) Otero has 15 years of experience in the biopharmaceutical industry, including in bioprocess development, manufacturing, and CMC of vaccines and complex biologics. He joined Turnstone Biologics from Seres Therapeutics, Inc., a leader in human microbiome therapeutics, where he was Vice President of Bioprocess Development and Manufacturing. At Seres Therapeutics, Dr. Otero oversaw the expansion of the bioprocess development and manufacturing group, and was the corporate team leader for the first synthetic microbiome therapeutic to enter Phase 1b clinical studies in the United States. Prior to that, Dr. Otero was Director of Engineering at Merck & Co.’s Vaccine Manufacturing Sciences & Commercialization division. In that role, he supported development programs for the Varivax™, Zostavax™, ProQuad™, and MMRII™ franchises. Prior to that role, he was Head of Fermentation Process Development, Vaccine Process Development within Merck Research Labs. Dr. Otero has authored more than 20 peer-reviewed publications. He earned a Ph.D. in chemical and biological engineering from Chalmers University of Technology in Gothenburg, Sweden, and an M.Eng. in biomedical engineering and a B.S. in chemical engineering from the Massachusetts Institute of Technology.
Steve Bernstein, M.D.
Senior Vice President, Clinical Research & Development
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.
David Stojdl, Ph.D.
Senior Vice President, 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.
Caroline Breitbach, Ph.D.
Vice President, Translational Development
Dr. Caroline Breitbach joined Turnstone Biologics from SillaJen Biotherapeutics (formerly Jennerex) where she was Vice President, Clinical and Translational Research. In that position, she oversaw translational and early-stage clinical development of an oncolytic immunotherapy and contributed to lead candidate development from Phase 1 through initiation of Phase 3 evaluation. Previously, she worked in Dr. John Bell’s group at the University of Ottawa, where she evaluated acute effects of oncolytic viruses on the tumor immune microenvironment. She earned a Ph.D. in biochemistry from the University of Ottawa and an Honor’s B.Sc. in microbiology and immunology from McGill University.
Maura Campbell, Ph.D.
Vice President, Corporate Affairs
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
Vice President, 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
Vice President, 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.
John Bell, Ph.D.
Ottawa Hospital Research Institute
Dr. John Bell began his independent research career at McGill University before moving to the University of Ottawa and becoming a professor in the Department of Medicine. He is a member of the Center for Innovative Cancer Therapeutics at The Ottawa Hospital Cancer Center and a Senior Scientist at the Ottawa Hospital Research Institute. He heads the Canadian Oncolytic Virus Consortium, a Terry Fox-funded group from across Canada that is developing virus-based cancer therapeutics, and is the Director of the Biotherapeutics Program at the Ontario Institute for Cancer Research. John is the Scientific Director of the National Centre of Excellence for the development of Biotherapeutics for Cancer Therapy and a Fellow of the Royal Society of Canada. Dr. Bell received a Ph.D. from McMaster University and then trained at the Medical Research Council in London, U.K.
Brian Lichty, Ph.D.
McMaster University
Dr. Brian Lichty is a distinguished scientist with extensive expertise in oncolytic viruses and related immunotherapies, including seminal work with Dr. John Bell at the Ottawa Regional Cancer Centre. He is a professor in the Department of Pathology & Molecular Medicine and the McMaster Immunology Research Centre (MIRC) at McMaster University. Dr. Lichty’s expertise includes influence research in the identification of strategies to leverage oncolytic viruses to harness the patient’s immune system in a sustainable manner, including vaccine design and engineering to directly engage the adaptive immune system tumor-specific and/or to enhance combinations with other immunotherapies. He is also director of the Robert E. Fitzhenry vector lab at McMaster University where clinical-grade viral vaccines are manufactured for human clinical trials. Dr. Lichty earned a Ph.D. from the University of Toronto and a B.Sc. from the University of Guelph.
David Stojdl, Ph.D.
University of Ottawa
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.
Brad Bolzon, Ph.D.
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.
Jerel Davis, Ph.D.
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.
Rishi Gupta, J.D.
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.
Sammy Farah, Ph.D., M.B.A.
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.
Patrick Machado
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.
Robert Gould
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.
Stefan Larson, Ph.D.
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.
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.
We are backed by top-tier investors who are committed to the company’s growth. We have raised approximately $50 million in venture capital financing since our inception.
Turnstone Biologics views strategic partnerships as a core component of our strategy and is interested in collaborating with biopharma companies, academic centers, and universities to transform patient care.
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 targeting a broad range of cancer indications.
In the fall of 2017, Turnstone Biologics entered into a strategic research, option and license agreement with AbbVie for our Ad-MG1-MAGEA3 therapy and two research-stage candidates.
Careers
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 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.
Team Member Openings
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 viral immunotherapies. We offer competitive compensation and benefits and are an equal opportunity employer.
Turnstone Biologics is a clinical-stage, immuno-oncology company focused on the development of next-generation oncolytic viral immunotherapies for patients with a broad range of solid tumors. Turnstone’s unique, first-in-class oncolytic viral immunotherapies combine the potent tumor-killing effects of an oncolytic virus with a tumor-targeted T-cell vaccine to harness an individual’s own immune system to attack the tumor, preventing recurrence and delivering a cure. Turnstone’s robust pipeline of early-stage compounds, based on its MG1 oncolytic virus platform, are in development for multiple solid tumors and are being evaluated in combination with other cancer immunotherapies, including checkpoint inhibitors, to drive unprecedented, durable T-cell immune responses and strong anti-tumor activity and prevent recurrence. Turnstone is building a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Turnstone has a seasoned board of directors and venture capital partners, is enrolling clinical studies, has a rich development portfolio, and highly active R&D efforts led by a world-class scientific management team. Turnstone is co-located in Ottawa, Hamilton, Canada and New York, USA.
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.
Position Overview:
The Director / Senior Director Human Resources will provide a full range of HR support, build and sustain relationships with all levels of Turnstone. This role will effectively influence analysis and decision-making in the areas of leadership, talent management and development, succession planning, change management, work force planning, organization development and design, performance management, talent acquisition and employee relations.
Responsibilities
Talent Acquisition
• Partner with the business leaders and hiring managers to establish and implement a vision for recruiting and retention strategy that drives the successful sourcing, recruitment and retention of targeted talent internally and externally.
• Develop and drive a strong employment brand that positions the company as an employer of choice within the industry.
• Work with managers to create job descriptions.
• Contribute to compensation strategy and offers.
• Evaluate and manage external vendors for job postings, recruitment, and sourcing.
• Review and assess candidates to determine fit with the company and the position.
• Coordinate with hiring managers and Executive Assistant to schedule phone and in-person interviews with potential candidates.
• Formulate and present employment offer packages.
• Manage applicant tracking system.
• Review and approve expense reimbursements for interviewing candidates.
• Ensure all pre-employment screening is complete.
• Provide guidance, direction, coaching, feedback, and training to hiring managers and employees.
• Train hiring managers and other interviewing panel on appropriate and effective interview techniques.
• Ensures that new hire information is communicated to relevant stakeholders across the organization. Coordinate on-boarding process with HR Manager, Facilities, IT, Finance and Quality.
Labor Laws and Regulations
• Proactively ensure that HR policies and practices are consistently applied and meet relevant labor laws and other regulatory requirements for both the US and Canada.
• Ensure consistency of written policies and employee informational materials with each other, as well as with state and federal regulations.
Employee Relations
• Coach/Advise managers and employees (issues resolution, performance management, etc.).
• Addresses employee relations issues including conflict resolution and workplace investigations; provides guidance and documentation related to disciplinary actions and termination.
• Respond to sensitive and confidential issues and concerns raised by all levels of employees in a confidential, timely, and objective manner. Maintain awareness of general employee issues concerns and recommend solutions.
Performance Management
• Coordinate and support annual and mid-year performance review process.
• Ensure manager and employees align individual goals to corporate and department goals and objectives.
• Coach managers and employees.
Compensation
• Update and maintain internal compensation documents and charts.
• Provide assistance in reporting compensation information to the survey vendors.
• Assist with the compensation analysis, review and adjustments.
Other Duties
• Conduct exit interviews and prepare summary reports.
• Prepare management reports as requested.
• Other HR initiatives and projects as needed
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. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.
Experience & Qualifications:
-
• BA/BS in Human Resources, Psychology, or related field required. PHR/SPHR a plus. Equivalent experience may be accepted.
• 12 – 15 years of professional level HR experience, including Human Resource Business Partner and Talent Acquisition roles.
• Experience working in Biotech or Pharma desired.
• Prior HRBP experience desired.
• Demonstrated ability to work in fast paced environment with geographically dispersed workforce.
• Self-motivated and self-confident individual who is able to forge and maintain strategic business partnerships and interface with all levels of employees in the organization.
• Knowledge of Federal Labor Laws and State Labor Laws and regulations
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 is a clinical-stage, immuno-oncology company focused on the development of next-generation oncolytic viral immunotherapies for patients with a broad range of solid tumors. Turnstone’s unique, first-in-class oncolytic viral immunotherapies combine the potent tumor-killing effects of an oncolytic virus with a tumor-targeted T-cell vaccine to harness an individual’s own immune system to attack the tumor, preventing recurrence and delivering a cure. Turnstone’s robust pipeline of early-stage compounds, based on its MG1 oncolytic virus platform, are in development for multiple solid tumors and are being evaluated in combination with other cancer immunotherapies, including checkpoint inhibitors, to drive unprecedented, durable T-cell immune responses and strong anti-tumor activity and prevent recurrence. Turnstone is building a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Turnstone has a seasoned board of directors and venture capital partners, is enrolling clinical studies, has a rich development portfolio, and highly active R&D efforts led by a world-class scientific management team. Turnstone is co-located in Ottawa, Hamilton, Canada and New York, USA.
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.
Position Overview:
If you are interested in being a part of a growing Manufacturing Sciences team, then this role may be for you! As a Scientist/Engineer, Manfacturing Sciences, you will report to the Manufacturing Sciences lead, within the Bioprocess Development and Manfuacturing Sciences team. With responsibilities spanning our multi-virus platform, key duties as they relate to this role will include:
• Batch Analysis, data analysis, data mining, data trending, and preparing the data for presentation to management
• Master Batch Record review, and field copy review
• Support the process development team through Drug Substance process scale up, and intensification for GMP manufacturing
• Participate in the development of a novel tech transfer strategy that can demonstrate success if/when travel is limited (COVID-19 restrictions)
• Lead the tech transfer of complex biologic processes between our external CDMO network spanning Canada, the United States, and Europe
• Lead engineering run campaigns at our external CMO network in preparation for GMP manufacturing
• Act as technical lead for investigation of process deviations and technical excursions
• Support drafting and reviewing of regulatory documentation
• Perform risk assessments across a variety of process, manufacturing, and equipment challenges
• Participate in equipment selection, procurement, and qualification processes
• Represent the Manufacturing Sciences team at Technical Operations cross-functional program meetings
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. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.
Experience & Qualifications:
-
Qualifications:
Turnstone Tech Ops is a virtual organization, where all of our wetbench work is executed third party CMO/CRO partners. We have offices in Ottawa, Canada and New York, USA – but considering the nature of our work and the global climate, this position can be stationed virtually – ideally within the Eastern time zone. This role is best suited for someone with the following:
• 5-7 years of overall experience within the biotech/pharmaceutical industry
• Bachelors degree in Science / Engineering, with a Master’s or PhD considered an asset.
• Trained in one of the following fields: chemical engineering, biology, biochemistry, or virology
• Basic knowledge of cell biology, and virology
• Experience working with biologic processes (viruses) considered an asset
• Experience with aseptic manufacturing processes (non-terminally sterilized drug substance) considered an asset
• Excellent computer skills, including Microsoft Excel and Powerpoint
• Excellent data analysis capabilities including statistical methods. Experience with statistical software, e.g. JMP, SAS, considered an asset
• Enjoy data mining, trending, and graphing data for presentation within reports or at meetings
• Excellent written communication skills to enable drafting of reports and risk assessments
• Previous experience drafting or reviewing Batch Records considered an asset
• Knowledge of GMPs considered an asset
• Self-motivated and efficient, able to manage responsibilities with an appropriate sense of urgency, and function effectively in a fast-paced and dynamic environment
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 is a clinical-stage, immuno-oncology company focused on the development of next-generation oncolytic viral immunotherapies for patients with a broad range of solid tumors. Turnstone’s unique, first-in-class oncolytic viral immunotherapies combine the potent tumor-killing effects of an oncolytic virus with a tumor-targeted T-cell vaccine to harness an individual’s own immune system to attack the tumor, preventing recurrence and delivering a cure. Turnstone’s robust pipeline of early-stage compounds, based on its MG1 oncolytic virus platform, are in development for multiple solid tumors and are being evaluated in combination with other cancer immunotherapies, including checkpoint inhibitors, to drive unprecedented, durable T-cell immune responses and strong anti-tumor activity and prevent recurrence. Turnstone is building a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Turnstone has a seasoned board of directors and venture capital partners, is enrolling clinical studies, has a rich development portfolio, and highly active R&D efforts led by a world-class scientific management team. Turnstone is co-located in Ottawa, Hamilton, Canada and New York, USA.
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.
Position Overview:
This position is a 6 month contract with the opportunity for renewal, pending the assessment of project outcomes, resource allocations, and mutual assessment of it.
Responsibilities include:
• Perform technical review of analytical data for completeness, accuracy, and GxP compliance in a timely manner to support critical timelines for delivering investigational drug to clinical trials
• Support the execution of new launches, processes and procedures, perform multi-batch trend analysis and compile study documentation
• Work with Quality Control colleagues, vendors, and cross functional teams to support investigations and projects
• Perform Raw material review and assessment for compliance with compendial requirements and specifications.
• Stays up to date on new SOPs, procedures, and techniques via training sessions, team meetings, and internal communication avenues
• Supports designing and implementation of Quality control projects to comply with GxP, regulatory, and Turnstone policies.
• Support management of inventory for QC reference standards, cell banks, and GxP materials
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. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.
Experience & Qualifications:
-
Qualifications:
• 2+ years of hands-on experience in the lab performing and data review of methods such as:
o virological and cellular assays (tissue culture, plaque assay, etc)
o molecular assays (qPCR, PCR, ELISAs, Western blot, etc)
o Compendial methods (Sterility, Endotoxin, Mycoplasma, adventitious agents etc)
• Education: diploma or degree in microbiology, biochemistry, biotechnology, or relevant field
• 2+ years experience in Quality control performing product release testing and review
• Knowledge in biological drugs such a viral vaccines, gene therapy, and cell therapies an asset
• Experience using Microsoft applications (Excel, Word, PowerPoint)
• Experience with analytical software such as JMP would be an asset
• Must have knowledge of GMP regulations
• Good organizational and time management skills
• Demonstrated attention to details
• Excellent communication and able to work with different teams
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 is a clinical-stage, immuno-oncology company focused on the development of next-generation oncolytic viral immunotherapies for patients with a broad range of solid tumors. Turnstone’s unique, first-in-class oncolytic viral immunotherapies combine the potent tumor-killing effects of an oncolytic virus with a tumor-targeted T-cell vaccine to harness an individual’s own immune system to attack the tumor, preventing recurrence and delivering a cure. Turnstone’s robust pipeline of early-stage compounds, based on its MG1 oncolytic virus platform, are in development for multiple solid tumors and are being evaluated in combination with other cancer immunotherapies, including checkpoint inhibitors, to drive unprecedented, durable T-cell immune responses and strong anti-tumor activity and prevent recurrence. Turnstone is building a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Turnstone has a seasoned board of directors and venture capital partners, is enrolling clinical studies, has a rich development portfolio, and highly active R&D efforts led by a world-class scientific management team. Turnstone is co-located in Ottawa, Hamilton, Canada and New York, USA.
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.
Position Overview:
Our Manufacturing Operations (MFG) team is growing. As part of the Technical Operations organization, the MFG team is responsible for GMP manufacturing of Virus Banks, Drug Substance and Drug Product for our clinical-staged assets. MFG supports technology transfers and collaborates closely with the Process Development & Manufacturing Sciences team to develop and capture process knowledge and ensure overall manufacturing success. As an Associate Engineer of Manufacturing Operations on the MFG team, you will report to the Associate Director, Manufacturing. 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 manufacturing campaigns with external CMO partners
– Support 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 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 MFG team at Technical Operations cross-functional program meetings
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. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.
Experience & Qualifications:
-
Qualifications:
• This Associate Engineer role will be formally positioned out of our New York, NY office but working from home/remotely will be the normal
• 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
• 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
• 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
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 is a clinical-stage, immuno-oncology company focused on the development of next-generation oncolytic viral immunotherapies for patients with a broad range of solid tumors. Turnstone’s unique, first-in-class oncolytic viral immunotherapies combine the potent tumor-killing effects of an oncolytic virus with a tumor-targeted T-cell vaccine to harness an individual’s own immune system to attack the tumor, preventing recurrence and delivering a cure. Turnstone’s robust pipeline of early-stage compounds, based on its MG1 oncolytic virus platform, are in development for multiple solid tumors and are being evaluated in combination with other cancer immunotherapies, including checkpoint inhibitors, to drive unprecedented, durable T-cell immune responses and strong anti-tumor activity and prevent recurrence. Turnstone is building a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Turnstone has a seasoned board of directors and venture capital partners, is enrolling clinical studies, has a rich development portfolio, and highly active R&D efforts led by a world-class scientific management team. Turnstone is co-located in Ottawa, Hamilton, Canada and New York, USA.
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.
Position Overview:
Our Manufacturing Operations (MFG) team is growing. As part of the Technical Operations organization, the MFG team is responsible for GMP manufacturing of Virus Banks, Drug Substance and Drug Product for our clinical-staged assets. MFG supports technology transfers and collaborates closely with the Process Development & Manufacturing Sciences team to develop and capture process knowledge and ensure overall manufacturing success. As a Senior Engineer (or Manager) of Manufacturing Operations on the MFG team, you will report to the Associate Director, Manufacturing. You will be tasked with leading 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:
– Lead manufacturing campaigns and serve as the primary interface with external CMO partners
– Lead manufacturing batch readiness including process definition, raw material procurement, and batch documentation preparation
– Lead ongoing batch monitoring including person-in-plant coverage
– Lead cross functional teams to troubleshoot and resolve issues with ongoing manufacturing runs
– Support 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 MFG team at Technical Operations cross-functional program meetings
– Serve as the primary interface with Bioprocess Development & Manufacturing Sciences, Quality Control, Quality Assurance, Supply Chain & Logistics, and/or Program Management on select projects, programs, and cross-functional workflows
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. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.
Experience & Qualifications:
-
Qualifications:
• This role will be formally positioned out of our New York, NY office but working from home/remotely will be the normal and actual location is flexible
• 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
• BSc in Chemical Engineering or in other related engineering discipline (biochemical, biological, biomedical, mechanical); MSc in a related scientific discipline also considered
• 5-7 years’ experience in a manufacturing operation, manufacturing sciences and technology, manufacturing technical support, or quality engineering role
• Experience with live virus based therapeutic manufacturing such as viral immunotherapies, vaccines, cell and gene therapies, or other complex biologics is considered important
• Experience with aseptic manufacturing processes such as the fill/finish of drug product and/or non-terminally sterilized drug substance is considered important
• Experience with good manufacturing practices (GMP) in an early clinical to late phase clinical manufacturing setting is considered important
• Experience managing external relationships such as CMO partners or clients as a CMO provider considered an asset
• 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 leading a cross-functional team in time sensitive, high pressure, and high-risk situations (e.g. manufacturing issue resolution) considered important
• Experience leading a team of direct reports is considered an asset
• 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
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 is a clinical-stage, immuno-oncology company focused on the development of next-generation oncolytic viral immunotherapies for patients with a broad range of solid tumors. Turnstone’s unique, first-in-class oncolytic viral immunotherapies combine the potent tumor-killing effects of an oncolytic virus with a tumor-targeted T-cell vaccine to harness an individual’s own immune system to attack the tumor, preventing recurrence and delivering a cure. Turnstone’s robust pipeline of early-stage compounds, based on its MG1 oncolytic virus platform, are in development for multiple solid tumors and are being evaluated in combination with other cancer immunotherapies, including checkpoint inhibitors, to drive unprecedented, durable T-cell immune responses and strong anti-tumor activity and prevent recurrence. Turnstone is building a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Turnstone has a seasoned board of directors and venture capital partners, is enrolling clinical studies, has a rich development portfolio, and highly active R&D efforts led by a world-class scientific management team. Turnstone is co-located in Ottawa, Hamilton, Canada and New York, USA.
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.
Position Overview:
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.
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. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.
Experience & Qualifications:
-
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 is a clinical-stage, immuno-oncology company focused on the development of next-generation oncolytic viral immunotherapies for patients with a broad range of solid tumors. Turnstone’s unique, first-in-class oncolytic viral immunotherapies combine the potent tumor-killing effects of an oncolytic virus with a tumor-targeted T-cell vaccine to harness an individual’s own immune system to attack the tumor, preventing recurrence and delivering a cure. Turnstone’s robust pipeline of early-stage compounds, based on its MG1 oncolytic virus platform, are in development for multiple solid tumors and are being evaluated in combination with other cancer immunotherapies, including checkpoint inhibitors, to drive unprecedented, durable T-cell immune responses and strong anti-tumor activity and prevent recurrence. Turnstone is building a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Turnstone has a seasoned board of directors and venture capital partners, is enrolling clinical studies, has a rich development portfolio, and highly active R&D efforts led by a world-class scientific management team. Turnstone is co-located in Ottawa, Hamilton, Canada and New York, USA.
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.
Position Overview:
In this role, you will have the opportunity to lead a team of dedicated and high-performing scientists to direct the development and qualification of analytical assays for release and characterization testing of our platform technologies of novel biotherapeutics, from live virus products to synthetic peptide vaccines. This team also heavily supports analytics for preclinical animal studies. Current products are in early clinical development and so many assays are at the starting line of their analytical life cycle management. This is an opportunity to establish rigorous and far reaching processes for assay qualification and validation, with an eye to Phase 3 and beyond. This role will necessitate partnering very closely with many other teams within Technical Operations (Bioprocess Engineering, Manufacturing Sciences, Quality Control, Analytical Operations, Quality Assurance), Regulatory Affairs, and Research (preclinical studies) to generate assays that are relevant and cutting edge. The associate director of analytical development will also be involved at times in meetings with external parties in support of regulatory interactions, diligence meetings, business partnerships, etc. This role will have elements of technical oversight, helping the team strategize and investigate technical problems, and operational oversight, ensuring that resources are used wisely and the team is supported in their efforts.
We are looking for a scientist that enjoys working as a team and growing as a leader, someone that believes that WHAT we do and HOW we do it are both critical to success. We are looking for a leader that can prioritize a heavy workload where resources are always limiting, supporting higher level discussions around regulatory implications and employee career development, as well as someone that is willing to roll up their sleeves and pitch in on the ground floor when required. You’ll have experience working with some or all the following, as they relate to analytical development:
Priority areas of interest:
• Biophysical and analytical chemical methods that support particle measurements, virus particle state assessment, and protein profiling with special attention to HPLC-based methods. Understanding of other related methods such as LC-MS, DLS, zetasizer, nanosight, FFF-MALS, etc are considered an asset.
• In depth knowledge of the methods, instruments, and regulatory considerations of next generation sequencing and it’s use in GMP environments considered an asset
• Experience developing qPCR methods for GMP an asset
Secondary areas of interest (already well supported within the team, but further asset in understanding critical methods): Cellular and molecular methods such as virus titering by plaque assay, genome quantitation by qPCR, impurity assessment by ELISA or qPCR, etc.
• Developing analytics for biological product characterization and release, experience with live virus products an asset
• Engaging in discussions with colleagues on their analytical needs, assessing/investigating various technologies to support those needs, and making decisions on technologies to pursue
• Supporting Quality Control scientists in their suspect results investigations to ascertain root cause and path forward
• Developing methods to support GMP product characterization or release and supporting the method life cycle management
• Developing methods to support preclinical studies to interrogate virus or protein levels in animal tissues – GLP knowledge an asset
• Performing or managing assay qualification and validation according to principles in ICH Q2, especially as is appropriate to support early clinical development
• Working closely with external CROs and vendors to drive projects to completion in a timely and scientifically sound manner
• Act as subject matter expert in analytical development during diligence and regulatory interactions
• Experience working within GMP quality systems is a must (change control, deviations, corrective and preventive actions, document control)
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. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.
Experience & Qualifications:
-
Qualifications:
This role is best suited for a scientist with 8+ years experience in directly leading analytical method development and qualification of complex biologics in support of GMP clinical product release, leading complex projects, and supporting regulatory submissions. Candidates for this roles will have directly coached and supervised a team of analytical scientists for at least 5 years and worked with external vendors to achieve a project goal. Candidates have likely achieved either a Masters or PhD in a relevant scientific discipline and are looking to use their knowledge in a meaningful and impactful way, while also learning about new methods, products, and processes. Candidates with less formal academic training may also be considered, but having more deep, diverse, and extensive experience will be crucial. Learning agility is critical as the methods leveraged by the Turnstone CMC analytics team are extremely broad and cutting edge. Candidates have demonstrated the ability to manage both small and large projects, multi-tasking effectively, and having an external presence that is professional, collaborative, and influential.
Travel during the COVID-19 pandemic is highly restricted and unlikely to be necessary. However, upon resumption of regular office life, you will need to travel on occasion to our various vendors (global) and also visit our Ottawa and NYC offices often to stay connected, productive, and excited. This role will report to the Director of Analytical Development and Quality Control at Turnstone. Based on a mutual discussion of fit, the successful candidate(s) will reside at either the Ottawa or New York office location, though special consideration will be given to anyone living in eastern North America who is able to travel on occasion (post COVID-19).
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.
Notice to Recruiters: Turnstone Biologics values our recruiting partnerships, but to protect the interest of all parties, we do not accept unsolicited resumes from recruiters. All recruiting is managed through our human resources department.
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Contact
Ottawa
12 York Street, 3rd Floor,
Ottawa, ON K1N 5S6, CA
(613) 421-8930
New York City
920 Broadway, 16th Floor,
New York, NY 10010, US
(347) 897-5988