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 Manager (or Sr Manager), Supply Planning will be responsible for investigational product (IP) supply for a clinical development program which is rapidly maturing and expanding to multiple global jurisdictions. The intent of the role is to start with a focus on our active early phase viral immunotherapy clinical studies, with potential opportunities to support other product modalities and product intermediates.
The responsibilities for this position include but are not limited to:
- Lead the integration of the clinical development plan and the manufacturing plan to create an actionable, end-to-end, long range strategic supply plan
- Lead the constant iterative re-modeling of supply plan scenarios to help inform program-level and functional-level decision-making across clinical development and technical operations
- Lead manufacturing campaigns at label-and-pack contract manufacturing organization (CMO) partners to create finished goods (FG/IP) ready for clinical distribution
- Partner with Regulatory Affairs and Clinical Operations to develop and manage IP and ancillary product labels for multiple jurisdictions
- Lead selection, strategic integration, and activation, and ongoing operation of clinical supply depots for IP, ancillary supplies, and other stored materials required for global clinical trials
- Monitor clinical IP supplies at sites and depots and provide supply metrics to support clinical operations needs around the globe
- Lead relationship management of label-and-pack CMO partners and the evaluation and selection of new CMO partners
- Lead GMP inventory management, including the tracking of actual inventory, as well as driving development of the tools, systems, and naming conventions utilized to enable efficiency and compliance
- Serve as a key stakeholder in the Technical Operations and Clinical Operations interface, including leading cross-functional meetings and teams to achieve integration of workstreams (production planning, testing planning, clinical operations, etc.)
How do you know if you’re the right fit?
- This Manager (or Sr Manager) role will be formally positioned out of our San Diego, CA office but working from home/remotely will be a part of the normal work routine
- Willingness to travel (during normal times) up to 10-20% to other Turnstones sites and/or external CMOs throughout North America (USA, Canada) and Europe
- BS degree in a relevant life sciences, engineering, or business management discipline
- 5-8 years’ experience in a clinical supply chain management across early to late phases of clinical development and multiple jurisdiction (Europe, Asia-Pacific, North America)
- 3-5 years’ experience in a team and/or cross-functional leadership role
- Strong understanding of and experience with GMP and GCP requirements
- Experience with implementation and operations of ERP (Oracle, SAP or NetSuite) and Interactive Response Technology (IRT) systems
- Experience working with and managing multiple third-party/external partners
- Experience with global clinical trials, ultralow cold chain, and sourcing of comparator IMPs highly preferred
- Excellent Excel abilities required
- Teamwork – willingness to lead and willingness to be lead when it’s appropriate
- Positive Attitude – ability to adapt to fast-growing teams and a dynamic virtual working environment
- Communication - must be able to communicate effectively cross functionally with multiple levels in the organization and externally to global partners
- Growth mindset – constant approach of challenging oneself to learn more, learn faster, and learn better
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