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?
Our Virus Manufacturing (VMFG) team is growing. As part of the Technical Operations organization, the VMFG team is responsible for the GMP manufacture of Cell Banks, Virus Banks, Drug Substance and Drug Product for our clinical-stage assets. VMFG supports technology transfers and collaborates closely with the Virus Development & Manufacturing Sciences team to develop and capture process knowledge and ensure overall manufacturing success. As an Associate Engineer of Virus Manufacturing on the VMFG team, you will be tasked with supporting manufacturing campaigns from end-to-end within our external contract manufacturing organization (CMO) network.
The responsibilities for this position span across our multi-modal platform and include:
- Support virus manufacturing campaigns with external CMO partners
- Support virus manufacturing batch readiness including process definition, raw material procurement, and batch documentation preparation
- Support ongoing batch monitoring including person-in-plant coverage
- Support cross functional teams troubleshooting and resolving issues with ongoing manufacturing runs
- Support virus manufacturing campaign closeout including the review of executed batch records and shipping/logistics of finished material
- Support process development, engineering runs, and other process scale-up related studies
- Support the identification and selection of new external CMO partners
- Support drafting of regulatory documentation including INDs, CTAs, etc.
- Represent the Virus MFG team at Technical Operations cross-functional program meetings
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 co-functional leader. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!
We are in the early stages of building strategies, structures and process 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 are the right fit?
· This Associate Engineer role will be formally positioned out of our Ottawa, Canada office
· Willingness to travel (when it’s safe as it pertains to global pandemic) up to 10-30% to other Turnstone sites and/or external CMOs throughout North America (USA, Canada) and Europe
· BS in a science, engineering, or biotechnology related discipline; MS considered an asset
· 1-3 years’ experience in a technical operations or research/development role
· Experience with live virus based therapeutic manufacturing such as viral immunotherapies, vaccines, cell and gene therapies, or other complex biologics
· Experience with good manufacturing practices (GMP) in a clinical or commercial manufacturing setting
· Experience with the qualification and operational use of single use, small scale mammalian cell culture, tangential flow filtration, and/or chromatography-based purification equipment and raw materials
· Comfortable in a dynamic environment with competing priorities
· Strong technical writing skills
· Teamwork – willingness to lead and willingness to be lead when it’s appropriate
· Positive Attitude – interest in learning how to adapt to fast-growing teams and a dynamic virtual working environment
· Communication - interest in learning how to communicate effectively cross functionally with multiple levels in the organization and externally to global partners
· Growth mindset – constant approach of challenging oneself to learn more, learn faster, and learn better
· Excellent computer skills, including Microsoft Excel and PowerPoint
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.