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.
• Perform technical and quality review of analytical data for completeness, accuracy, and GMP compliance in a timely manner to support clinical timelines and regulatory submissions – these reviews will require close partnership with the analytical SMEs and a working knowledge of molecular and cellular techniques used for the characterization and release of complex biological drug product
• Support the execution of new launches, processes and procedures, perform multi-batch trend analysis and compile study documentation
• Being an engaged and diligent member of the Quality Control team, working with internal and external stakeholders to support investigations and projects
• Perform raw material review and assessment for compliance with compendial requirements and specifications
• Stay up to date on new SOPs, procedures, and techniques via training sessions, team meetings, and internal communication avenues
• Support design and implementation of Quality Control projects to comply with, and further improve our approach to, GMP regulations and Turnstone policies – Turnstone is a quality centric organization and as such, the QC team and approach are valued and empowered to ensure patients receive quality therapies
• Support management of inventory for QC samples, reference standards, cell banks, and GxP materials
Experience & Qualifications:
• 2-6 years of hands-on experience in the lab performing and data review of methods such as:
· virological and cellular assays (tissue culture, plaque assay, etc)
· molecular assays (qPCR, PCR, ELISAs, Western blot, etc)
· Compendial methods (Sterility, Endotoxin, Mycoplasma, adventitious agents, etc)
• Education: diploma or degree in microbiology, biochemistry, biotechnology, or relevant field – higher education in a relevant field is considered an asset and would be considered towards the hands-on experience
• Experience in Quality Control performing product release testing and review would be an asset
• Knowledge in vaccines, peptides, or small molecules would be an asset
• Experience using Microsoft applications (Excel, Word, PowerPoint)
• Experience with analytical software such as JMP would be an asset
• Must have knowledge of GMP regulations
• Good organizational and time management skills
• Demonstrated attention to detail
• Excellent communication and ability to work with different teams
• Ability to excel in a fast paced environment
• Turnstone prides itself in its open, accepting, and respectful culture – applicants must exemplify and hold up these values, always aiming for a trusting relationship with colleagues, where everyone is heard and respected.
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.