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 work flows 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. To support this goal, the team will also oversee all unit operations, from molecular diagnostics to peptide chemistry at our global network of contract manufacturing organizations. The team will work closely with the cell therapy development team to support tech transfers to GMP partners, capturing process knowledge and ensuring a smooth transition. As the Associate Director of the Cell Therapy Manufacturing team, you will report to the Director of Global QC and Cell Therapy Manufacturing.
The responsibilities for this role include:
- Establishing workflows, SOPs, and practices for manufacturing operations at external CMO partners
- Growing the Cell Therapy Manufacturing team to meet the evolving clinical needs
- Leading cell therapy manufacturing campaigns with external CMO partners
- Support manufacturing batch readiness including process definition, raw material procurement, and batch documentation preparation and/or revision
- Support ongoing batch monitoring including person-in-plant coverage
- Participate in cross functional teams troubleshooting and lead deviation investigations with ongoing manufacturing runs
- Lead autologous product 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
- Lead the identification and selection of new external CMO partners
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 leader. Passionate about being a part of a critical function of a growing company and continuous learning? You will be engaged in building a team and a work flow 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?
· This role will be formally positioned out of San Diego, California or Ottawa, Canada
· 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
· MSc or PhD in Cell Biology, Immunology, or a related scientific discipline (biomedical, bioengineering, etc)
· 7-10 years of experience in a manufacturing operation, manufacturing sciences and technology, or manufacturing technical support role
· Experience with the manufacturing and operational complexity of cell therapy-based therapeutics such as TIL, CAR-T, TCR products, especially experience with autologous therapies is considered very important
· Understanding of aseptic manufacturing processes and related risk assessments and mitigation strategies
· A depth of understanding of current good manufacturing practices (GMP) in an early clinical to late phase clinical manufacturing setting
· 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
· Comfortable leading a cross-functional team in time sensitive, high pressure, and high-risk situations (e.g. manufacturing issue resolution)
· Experience leading a team of direct reports and building a team from the ground up
· 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
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.