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 Sr. Engineer/Sr. Scientist of upstream process development, you will report to the Head of Drug Substance Process Development. As part of this role, you will lead all of the technical aspects of our virus process development program across cell line, media/feed strategies, infection/harvest and bioreactor scale up and development. You will be a critical member of our Process Development team and help contribute to the overall strategy and execution of our virus CMC and translation. Specifically, you will:
· Develop the upstream process development targets and strategy to reach our program needs across a suite of virus-based drug products
· Contribute as the subject matter expert to the overall upstream process development of our virus pipeline supporting cell line development, media development, feed strategy development, infection and harvest conditions, and bioreactor scale up
· Lead interactions with our external CDMO network to accomplish efficient process development advancement
· Collaborate with Drug Product development, Manufacturing Sciences and Manufacturing Operations to support smooth translation of processes through inception to clinical manufacturing
· Participate in technology transfer of our processes to local and international GMP partners
· Support Manufacturing Sciences team with scale-up of the manufacturing processes, and deviation investigations
· Employ QbD principals to perform process characterization studies
· Act as subject matter expert for review of data in regulatory filings
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 CMO/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:
· Scientist or Engineer with advanced degree in Biochemical Engineering, Biotechnology or in other related Science field (virology, biology, biochemistry, protein chemistry, pharmaceutical chemistry)
· 5-7 years of experience in upstream process development within biotech/pharma
· 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
· Proven expertise and technical depth in upstream process development (mammalian cell culture expression systems, ideally for the manufacture of live-viruses) is required
· Experience with media and feed development strategies
· Expertise in microcarrier, and aseptic process experience, is strongly preferred
· Experience leading bioreactor development workstreams and support scale up from benchm, to pilot, to GMP scale SUB
· Excellent communication skills with the proven ability to build open and collaborative relationships, work effectively as a member of a multidisciplinary team
· 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
· Excellent computer skills, including JMP, Microsoft Excel, Powerpoint and Word
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.