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.
If you are interested in being a part of a growing Regulatory Affairs and Quality Assurance team, then this role may be for you! As the Associate Director, Cell Therapy Quality Assurance, Reporting to the Head of Quality you will establish and implement the quality strategy which enables GXP compliance in accordance with country regulations and guidelines, as well as the company’s policies and procedures. The focus will be on GMP for the Turnstone cell therapy platform, with strong interfaces to the technical operations teams, clinical operations teams (GCP) and pre-clinical/R&D team (GLP), as well as a strong partnership to the Turnstone virus platform.
1. Some QA professionals will provide regulatory guidelines, guidance documents, position papers, or other resources that are supplied by various regulatory bodies and/or trade organizations to help guide development. We are not looking for someone to provide those resources. We are looking for someone who deeply understands our science, our patients, our products, and our context, and provides interpretations, proposals, recommendations, and solutions of how we might apply those resources. We need hands-on problem solvers.
2. Some QA professionals will review development, manufacturing, and testing approaches, SOPs, batch records, and supply chain documentation and identify deviations, gaps, issues, and challenges that need to be addressed, and then pass those on. We are looking for a QA professional where supply of product – compliant, right-first-time, all the time, every time – is part of their core responsibilities. QA is as responsible for supply as manufacturing operations, manufacturing sciences, project management, QC regulatory affairs, and everyone else in the team. We own it, together.
If you share the above core philosophy, then below are some of the activities you will channel those core beliefs into:
· Develop, establish and maintain QA programs, policies, and procedures to ensure GxP compliance of clinical trial material.
- Manage the oversight of contract manufacturers and research organizations to ensure products/deliverables meet all required quality standards and specifications.
· Perform rapid and agile record review and disposition activities for clinical trial material including manufacturing, testing and labelling/packaging batch records
· Lead extensive investigations with vendors and interdepartmental teams to determine product quality impact and resolve potential product quality issues.
· Oversee the generation, review and/or disposition of internal and external documents used in GxP activities.
· Act as the single point of QA contact with vendors, contract facilities and joint development collaborators for contracts, validation activities, change management and other QA issues
· Drive the implementation of other quality systems, including departmental and corporate procedures, to ensure compliance with GxPs.
· Interpret regulatory agency policies and guidance as it pertains to QA issues.
· Review CMC documents submitted to regulatory agencies.
· Develop work instructions and/or standard operating procedures
What’s in it for you?
In this role, you will have the opportunity to develop your a
We are in the early stages of building strategies, structures and process so this role will be busy and expanding. We also have opportunities for you to be a mentor to other team members. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.
This role is best suited for someone with the following:
- BA/BS Degree, with an advanced degree preferred
- Minimum of 8+ years of operational quality assurance and GxP compliance. Requires manufacturing experience in a pharma or biotech environment, ideally across a full range of multiple clinical development phases
- Prior experience with quality systems and advancing novel autologous therapeutics from preclinical stages through IND to BLA (or EU equivalents) is desired. Understanding of the biologics and cell therapy manufacturing process in GXP environments.
- Experience with regulatory authority or client/partner inspections/audits, and conduct of supplier/manufacturer audits.
- Knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
- Strong knowledge of current industry trends and the ability to use the latest technologies
- Experience with computer system validation (CSV) and knowledge of CFR Part 11 compliance would be an asset.
- Demonstrated ability to manage multiple projects and variable workloads with demanding timelines.
- Strong interpersonal, teamwork, and organizational skills; effective oral and written communication skills.
· The candidate must exude a mature communication style that matches the Turnstone style: respectful, transparent, with a high degree of integrity and humility
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.