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 workflows 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. This position would report to the Director of Cell Therapy Manufacturing.
What’s in it for you?
In this role, you will have the opportunity to develop your ability to think strategically, technically, and drive fast-paced execution. With our company size and growth, we will give you plenty of opportunities 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 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 Ottawa, Canada or San Diego, California though consideration will be made for remote candidates in North America
· MSc or PhD in Cell Biology, Immunology, Chemical Engineering, Biomedical Engineering, or a related scientific discipline
· 5-8 years of relevant experience in a manufacturing operation, manufacturing sciences and technology, or manufacturing technical support role
· Experience with processing and scale-up of mammalian cells or similar and optimization of processes relevant to cell and gene therapy
· Direct experience with cell and gene therapy or regenerative medicine
· Experience with the manufacturing and operational complexity of cell therapy-based therapeutics such as TIL, CAR-T, TCR, or stem cell products is an asset
· 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
· Independent, detailed-oriented, self-starter with excellent analytical skills with the ability to multi-task and succeed in a team environment
· Experience in statistical design and analysis
· Able to manage competing priorities effectively and adapt to changing priorities
· Ability to work independently and as part of a team
· Strong technical writing skills
· Strong communication both written and spoken
· Task & Team-oriented, analytical, organized, detail-oriented, self-motivated & ability to multi-task
· Strong interpersonal skills and a communication style that matches the Turnstone style: respectful, transparent, and constant
· Excellent computer skills, including Microsoft Excel and PowerPoint
The responsibilities for this role include:
· Review of manufacturing data for trends, indications of process improvement requirements or indicators of manufacturing failure causes
· Establishing appropriate parameters for in-process testing and feedback on critical process parameters
· Batch production record review upon changes and after manufacturing
· Support in management of process deviations and assessing impact to the final product
· Person in plant
· Prepare and/or coordinate with contract testing organizations for analytical methods, protocols, reports and other documents related to analytical development and qualification/validation activities
· Keep up to date with scientific and technical developments
· Responsible for complex decision making, optimization and troubleshooting of methodologies
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.