Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies for the treatment of solid-tumor malignancies – the highest unmet medical need in oncology today. Turnstone is a product development team 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. Turnstone’s proprietary 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 are agnostic to technology, modality, or complexity and willing to combine product development opportunities that bring truly differentiated therapeutic biology to solid-tumor cancer patients– we will tackle anything from a CMC perspective if it advances our mission. We continue to build a worldclass, 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?
This is an opportunity to build the Cell Therapy Manufacturing team in partnership with Tech Ops Leadership. We are growing quickly and establishing our work flows and practices to ensure operational excellence, fitfor-purpose, at every stage of development. As a core team within TechOps, 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 to TIL expansion at our global network of contract manufacturing organizations, and be pivotal in exploring when, how, and to what degree internalization of manufacturing operations should occur.
The ultimate goal is to have manufacturing leadership, infrastructure, and expertise such that we remain in full control of our own destiny. 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 Director of the Cell Therapy Manufacturing team, you will report to the Senior Director of CMC and QC (core member of TechOps Leadership Team reporting to the Chief Technology Officer, member of the executive team).
The responsibilities for this role include:
- Establishing workflows, SOPs, and practices for manufacturing operations at external CMO partners
- Growing, hiring, coaching, mentoring, and developing the Cell Therapy Manufacturing team to meet the evolving clinical needs
- Leading cell therapy manufacturing campaigns with external CMO partners, serving as the principal external facing leader of Turnstone cell therapy manufacturing operations
- 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, in very close partnership with the cell therapy development team and R&D
- 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
- Lead manufacturing sciences, building a robust approach for process data collection, analysis, and interpretation
- Influence and contribute to the development of Turnstone’s cell therapy manufacturing strategy and roadmap, informing key decisions around external CDMO supply network vs. internal manufacturing capabilities/infrastructure.
- Serve as a key member of the Extended TechOps Leadership Team, aiming to develop the next generation of talent amongst our scientific and engineering leaders, and group leaders.
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 workflow 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, Chemical Engineering, Biomedical Engineering or a related scientific discipline
• 7-10 years of relevant 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, or stem cell 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 is important, with commercialization experience as a bonus
• 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, developing, and coaching a team of direct reports, while also 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
• Strong data analysis skills, with familiarity with JMP or similar data analysis tools
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.