Turnstone Biologics (“Turnstone”), a public 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 trial in solid tumors for the lead TIL therapy candidate, TIDAL-01, and a Phase 1 trial in partnership with the Moffitt Cancer Center.

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.

POSITION OVERVIEW

We are seeking a highly effective, self-motivated, and versatile Quality Assurance professional with demonstrated knowledge of, and experience in, end to end manufacturing operations. As QA Specialist you will support the team with a variety of manufacturing processes, test methods, laboratory techniques, and material changes, improvements, and innovations. You will be responsible for ensuring that such changes and projects are executed in accordance with sound change management principles and Turnstone-defined procedures. This role is critical in maintaining a strong partnership with our contract development and manufacturing organizations (CDMOs) in pursuit of advancing our pipeline and is expected to be hands-on in the operational details of the Manufacturing and Quality support at CDMOs.

RESPONSIBILITIES

• Supports the evaluation and disposition of labelling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results, and other GMP documents.
• Participate in the overseeing of deviation, change control, and CAPA programs as well as creates, owns, and manages deviations, change control requests, and CAPA records pertaining to their functional areas.
• Initiates and/or reviews and approves manufacturing process deviations.
• Reads, understands, and follows SOPs, and complies with GMP.
• Writes new standard operating procedures or revises existing documentation utilizing document management systems.
• Assists in the implementation of new processes.
• Electronic system usage with tools such as Veeva and LearnGxP.
• Assists supervisor by assembling metrics as requested for their functional area.
• Identifies, coordinates, and implements continuous improvements.
• Prioritizes day-to-day support for their functional area and longer-term projects or investigations.
• Integrates knowledge and experience as skilled specialist with knowledge of corporate and industry standards with respect to their functional area.
• Creates/revises QA documents (gap assessments, risk assessments, reports) in document management system.
• Facilitates and coordinates training of new and existing team members, prepares training materials as necessary.
• Represents QA, as needed, during meetings relevant to their functional area, communicates and tracks all follow-up items through to completion
• Additional duties as assigned.

QUALIFICATIONS

• Bachelor’s in Biology, Microbiology, Engineering or science-related field preferred.
• 2-4 years industry experience, preferably in gene and cell therapy.
• 2 years of QA experience.
• Experience in GMP environments including knowledge of change management principles and industry standard QMS applications.
• Experience drafting and leading deviation investigations is considered an asset.
• Demonstrated ability to manage multiple tasks/projects with demanding timelines.
• Strong interpersonal, teamwork, and organizational skills; effective oral and written communication skills.
• Domestic travel up to 25% to support CDMO activities.

COMPENSATION

• 
  Healthcare Coverage: Medical, dental, and vision insurance for you and your dependents.
• Retirement Planning: 401(k) plan with employer contributions.
• Time Off: Generous paid time off, including vacation, sick leave, and holidays.
• Workplace Flexibility: Flexible schedules and remote work options.

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.