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 Analytical Life Cycle Management team is growing quickly and establishing workflows and practices to ensure analytical excellence of the QC test methods that are used for all stages of product manufacturing and GMP release and characterization of Turnstone’s novel biotherapeutics. Reporting into the Technical Operations department, this team is responsible for life-cycle management of current and future analytical methods and alignment with applicable policies and regulatory requirements. To support this goal, the team is responsible and accountable for continuous test method improvement activities, for enabling innovation, and for introduction of new technologies. The team works closely with Quality Control and contract testing organizations, overseeing qualification, and examining method performance and trending to support ongoing method optimization and improvements. As the Scientist of the ALCM team, you will report to the Associate Director of ALCM.
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 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
· Extensive experience developing and troubleshooting cell-based and potency assays and ensuring that life-cycle management of analytical methods is implemented and aligned with applicable policy and regulatory requirements
· Solid experience with other analytical techniques such as Flow Cytometry, Next Generation Sequencing, etc.
· Knowledge and experience in analytical method development, method validation, and method transfers.
· Working knowledge and application of GMPs/GLPs principles, ICH guidelines and compendial methods
· Experience in Cell therapy, vaccines, or biological products
· 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
· 5+ years of related experience in area of Pharmaceutical/Biologics industry
· M.Sc./Ph.D in Biological sciences or Life Sciences fields or B.Sc. with extensive industry experience.
The responsibilities for this role include:
· Develop Analytical Target Profiles for new and existing test methods
· Perform Lifecycle Management of Analytical Procedures: perform assessments of method validation/qualification and performance; identify gaps and required corrective actions; trend, analyze and interpret data.
· Perform analytical method development, method qualification/validation and method transfers
· 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.