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.
As a Sr. Engineer (depending on your relevant experiences and expertise), you will provide process development and engineering support for process design, characterization, and improvements with a goal of ultimately enabling GMP manufacturing. Primary responsibility will be to design, lead, and execute experiments that contribute to development and characterization of the TIL cell therapy manufacturing process. Experiments will be performed to identify and define Critical Process Parameters and process ranges. Additionally, you will draft and review study plans and reports, analyze and trend process data, perform Design of Experiments (DoEs), and provide technical support for manufacturing sciences, technology, and process changes. Turnstone works in a highly cross-functional environment, so your contributions will be critical for our pre-clinical, clinical, and regulatory workflows, with an opportunity to engage and enable your colleagues across the business.
· Develop manufacturing processes for cell therapy products and develop process improvements and efficiencies
· Lead and execute laboratory studies to support process design and development, characterization and process improvements
· Write and review technical documentation
· Participate and report to a cross-functional development team to advance production activities
· Assist in technology transfer to GMP manufacturing by generating development reports and providing on-site technical support.
· Authoring and assistance in the technical review of supporting documents, reports, including CMC sections for regulatory filings.
· This is a hands-on position requiring conducting laboratory experiments, good documentation review skills, good writing skills, and the flexibility to move between the management and execution of each required function as needed.
· Act as technical expert to train and supervise process technicians
Experience & Qualifications:
· Minimum of 5 years of relevant industry experience, with role flexibility available commensurate with experience
· Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical/biotech manufacturing & process development experience required
· Fluency with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
· Cell culture and aseptic processing experience
· Working knowledge of scientific and engineering principles
· Experience in statistical analysis using JMP or Minitab
· Practical experience in GMP operations
· Ability to function efficiently and independently in a changing environment
· Self-motivated and willing to accept temporary responsibilities outside of initial job description
· Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
· Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
· The primary location of the position is San Diego, but may be required to travel, based on business priorities
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.