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 1/2 a 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 2021/2022. 

 

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 CMC Development and Quality Control teams are growing quickly and establishing our work flows and practices to ensure excellence in Bioprocess and Analytic Development, as well as QC Analytics, Operations, and Compliance in support of Turnstone’s novel cancer immunotherapies and cell therapy products.  This is a transversal role reporting into the Technical Operations team, spanning both development (i.e. non-GMP) and Quality Control (i.e. GMP) spaces. This role bridges gap between TechOps in support of regulatory objectives.  The development team is tasked to create robust & phase-approprriate bioprocess and analytical strateiges for our RIVAL and TIDAL programs, while the the Quality Control team is responsible for the GMP testing, QC release, Shelf-life Stability, QC vendor management, and Compliance.

As the CMC Specialist/ Principal Specialist, you will report to the Associate Director of QC and will have the opportunity to work with all clinical-stage assets cross-functionally (viral and cell therapy), ensuring that TechOps meets our regulatory objectives and are supporting any regulatory submissions with appropriate documentation. 

 

The responsibilities for this role include:

·       Support the development and definition of the CMC content requirements based on regulatory and CMC strategies for timely submission of regulatory filings

·       Lead cross functional collaborations to coordinate gathering of source documents, peer review of CMC content, process development and analytical method reports supporting submissions

·       Write and review CMC content as well as coordinating authoring of technical & regulatory documents led by engineers and scientists within Technical Operations.

·       Summarize scientific information from development reports and identify details relevant to regulatory submissions

·       Evaluate data, author, and summarize reports and communicate outcomes to internal stakeholders

·       Work with Regulatory to maintain risk register, CMC commitments to regulatory bodies, and monitor the completion of commitments

·       Engage team by sharing risks and supporting strategy for risk mitigation

·       Work with Regulatory to ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations

·       Support assigned regulatory team member with compiling all CMC related submissions

·       Support response strategy, assemble supporting data, draft and manage responses to CMC queries and requests for Information received from global health authorities

 

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, you will have ability to create 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?  This is an opportunity to be an independent and self-directed contributor who will be responsible for converting scientific data into clear, scientifically sound, well-structured scientific, technical, and regulatory documents intended for global health authorities and internal and external stakeholders. The Technical Writer will author and manage the review and approval of CMC regulatory documents, including, technical reports, regulatory responses, source documents, and SOPs. You will be engaged in 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?

 

·       You are self-motivated and love working with people. You are collaborative, optimistic, and a solution seeker

·       Operational excellence and exceptional internal and external Stakeholder service are ingrained in your personality

·       You have excellent comprehension of bioprocess & analytical/scientific literature, medical and scientific terminology, and statistical methods

·       You have exceptional attention to details and can balance multiple activities in a complex environment, as well as meet critical deadlines.

·       You can independently plan, write, and edit submission documents across multiple therapeutic areas in compliance with ICH, FDA, and global regulatory guidelines and requirements

·       You have strong knowledge of a complement of FDA, EMA, ICH, USP, and EP guidelines and regulations for biological or cell therapy products

·       You are comfortable with minimal direction and able to adjust workload based upon changing priorities

·       You have aptitude to make informed, data-driven, and risk-based timely and strategic decisions

·       You strive to enable trust, build authentic relationships, constructively challenge conventional thinking, influence stakeholders, lead and cooperate in a team setting, share information, and deliver results

·       Strong communication both written and spoken

·       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

 

 

 

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.