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.
As the Head of Viral Bioprocess and Analytical Development (Senior Director or VP, commensurate with relevant industry experience) , you will be an important member of the Technical Operations leadership team reporting to the Chief Technology Officer. You will be responsible for providing overall direction of our analytical and process development strategy across Drug Substance and Drug Product for a portfolio of live virus therapeutics based in our RIVAL platform (highly engineered vaccinia virus). Among your responsibilities will be:
· Participate as an active member of the Technical Operations leadership team and contribute to overall company strategy for CMC and Technical Operations
· Provide leadership and guidance to a team of Scientists and Engineers, with the intent of being a leader of leaders
· Set the analytical development strategy for methods spanning process and product characterization, and collaborating closely with the analytical life-cycle and QC team for technology transfer of new release and characterization methods
· Lead the process development strategy for early phase clinical development, through pivotal and commercial drug substance (DS) manufacturing
· Support scale up and technical transfer of novel processes to GMP manufacturing partners
· Set the drug product (DP) image and work with Supply Chain to develop strategy for robust shelf life of all virus products
· Lead all aspects of clinical handling and administration to develop improved viral delivery systems (IV infusion, IT or IM injections) to enable optimization of pharmacy DP handling and administration
· Participate in a cross-functional matrix team (Clinical, Manufacturing, Supply Chain, Regulatory, Quality, Tech Ops) to develop overall DS development strategy for a suite of viral-based products (RIVAL pipeline)
· Provide a depth of technical leadership for DS process development spanning cell line and media development, cell strain optimization, bioreactor design, selection and control strategies, harvest, lysis, clarification, chromatography and separation/filtration technologies
· Represent Turnstone CMC externally at our expansive international CDMO network
· Participate in regulatory strategy and document authoring/reviewing for interactions with FDA, EMA, Health Canada, MFDS, and other jurisdiction as they emerge
· Drive corporate and departmental objectives to completion through strong collaboration with a broad range of internal functions, in particular Regulatory Affairs and Quality Assurance
What’s in it for you?
In this role, you will have the opportunity to develop your a
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 ‘WOW!’ all of us and grow right along with the company.
Turnstone Technical Operations is a virtual organization, where the majority of our wetbench work is executed at third party CDMO/CRO partners. We have offices in Ottawa, Canada and San Diego, USA and this role would ideally inspire you to relocate. Most of our virus development team is stationed in Ottawa and most of our partnerships are in Europe – therefore being in Ottawa would be ideal, but if you believe you can be successful in San Diego, we would love to speak with you! This role is best suited for someone with the following:
· 10+ years of overall experience within the biotech/pharmaceutical industry
· Minimum of 5+ years of leadership experience demonstrated as either having direct reports, and/or demonstrated leadership across complex projects and cross functional teams
· Scientist or Engineer with advanced degree (PhD strongly preferred but not required)
· Experience with process scale up, deployment and technology transfer of complex biological processes in a GMP manufacturing environment, and process qualification/validation are strongly preferred
· Strong interpersonal skills required
· Proven expertise and technical depth in upstream process development (mammalian cell culture expression systems, ideally for the manufacture of live-viruses), and/or downstream process development is required
· Educated in one of the following fields: Biochemical Engineering, Biological/Biomedical Engineering, Virology, Biology, or Biochemistry
· Broad exposure to different biological drug products. Experience working with viruses considered a very strong 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
· The candidate must exude a mature communication style that matches the Turnstone style: respectful, transparent, with a high degree of integrity and humility
· Able to manage competing priorities effectively and adapt to changing priorities
· Analytical and quantitative approach to problem solving, with the ability to self-start and independently investigate technically challenging problems
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.