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 Quality Control team is growing quickly and establishing our work flows and practices to ensure analytical and operational excellence in support of Turnstone’s novel cancer immunotherapies and cell therapy products. Reporting into the Technical Operations department, this team is responsible for the GMP testing, QC release, Shelf life Stability and QC vendor management program of our RIVAL and TIDAL products. To support this goal, the team oversees all GMP testing activities at our global network of contract testing organizations in addition to specification setting and management of inventory, cell banks, and critical reagents in accordance to regulatory and compendial requirements. The team works closely with Manufacturing, ALCM, and Contract organizations supporting product comparability, qualification, and tech transfers to GMP partners. As the Senior Scientist of the QC team, you will report to the Associate Director of QC and will have the opportunity to work with all clinical-stage assets (viral and cell therapy).
The responsibilities for this role include:
· Lead a small team of high-performing scientists, supporting them in their goals so that they can be the best versions of themselves every day, while being engaged and fulfilled. The team is small and flexible and will require a leader that is able and willing to roll up their sleeves and help in the day to day as much as build thoughtful systems supporting the team’s growth and operations.
· Manage the QC Lot release program for multiple products in early phase clinical development to meet corporate goals and clinic needs
· Perform analytical data review and provide technical expertise to support data review of viral and cell therapy-based methods for lot release, characterization, and stability testing
· Optimize and maintain a sustainable stability program management system for diverse products
· Design and develop stability testing/trending strategies to support shelf-life stability claims
· Implement systems to routinely analyze release and stability data and trends to support setting specifications, shelf life stability, organizational needs, and continuous improvement activities
· Develops and generate metrics and KPIs to capture RFT (Right First Time) supporting operational excellence initiatives
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 building 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
· Strong knowledge of a complement of FDA, EMA, ICH, USP, and EP guidelines and regulations for QC and stability program implementation of biological or cell therapy products
· Experience with implementation, optimization, and management of shelf-life stability programs for novel therapeutics
· Extensive knowledge of QC analytical testing supporting biologics, vaccines, or cell therapy products e.g. cell based assays, compendial methods, flow cytometry, cell counting, ELISA, PCR. Special consideration will be given to candidates with a working knowledge of next-generation sequencing technologies
· Self-motivated, comfortable in fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
· Ability to make informed, data-driven and risk-based timely decisions
· Strong aptitude to enable trust, build authentic relationships, constructively challenge conventional thinking, influence stakeholders, lead and cooperate in a team setting, share information, and deliver results
· Experience with QC analysis and investigations applicable to for e.g. products, raw materials, EM Programs, chemistry, microbiology, and molecular biology assays
· 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 statistical software such as JMP
· 8+ 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.
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.