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 1/2 a 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 2021/2022.
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.
What would it be like?
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:
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 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?
· 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
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.