Turnstone Biologics is a clinical-stage biotechnology company developing new medicines to treat and cure solid tumors by pioneering a differentiated approach to TIL therapy. Turnstone’s innovative TIL therapy is based upon the identification, selection, and expansion of the most potent tumor-reactive T cells, known as Selected TILs, and is designed to overcome the limitations of first-generation bulk TILs that have demonstrated objective responses only in limited tumor types. Turnstone’s most advanced program, TIDAL-01, is currently being evaluated in two Phase 1 studies in patients with melanoma, breast cancer and colorectal cancer, and the Company is also actively advancing its preclinical pipeline programs including TIDAL-02, its next Selected TIL program, and its TIDAL-01 and viral immunotherapy combination program.

 

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.

 

JOB DESCRIPTION

We are seeking an innovative, a self-motivated and versatile individual to join us as a Senior Manager, QC within the Quality organization. This is a key role focused on phase appropriate method qualification/validation, method life-cycle management, technical support of external manufacturing partners, including supporting method transfer, technical document authoring, person-in-plant activities, impact assessment, laboratory investigation, and method trending/monitoring. The candidate will work closely with Analytical Development, Process Development, Quality Assurance, Translational Science and Regulatory team members. This role is critical in developing a strong partnership with our CDMOs in pursuit of advancing our pipeline and is expected to be hands-on in the technical and operational details of the Manufacturing and Quality Control operation at CDMOs.

 

KEY RESPONSIBILITIES

  • Contribute to and implement method qualification and validation strategy. Accountable and responsible for implementing the detailed method qualification and validation strategy with key stakeholders.
  • Review and approve method qualification/validation protocols and reports.
  • Support person-in-plant activities at CDMO(s) as a technical method SME.
  • Support timely and accurate documentation in support of the various Quality records (laboratory investigation, deviations, impact assessments, CAPAs, change controls).
  • Provide hands-on technical support to laboratory investigation, deviations, non-conformance events, and ensure batch disposition decisions are guided by sound technical rationale.
  • Review executed test methods at the CDMO and ensure they meet the requirements of Turnstone’s process and regulatory guidelines.
  • Collaborate closely with Analytical Development to support, execute and/or provide oversight in the execution of method optimization, extended characterization, troubleshooting, transfer, and qualification/validation.
  • Develop, revise, review, approve, and own SOPs (Standard Operating Procedures) and technical (transfer, validation, bridging, etc.) protocols/reports.
  • Assist in reviewing data and assist with product and assay control trending and monitoring.
  • Additional duties as assigned.

 

REQUIREMENTS

  • Bachelor’s or Master’s degree with demonstrated experience in cell therapy, immunology, cancer biology or a closely related field, and 7+ years of industry experience, preferably in gene and cell therapy.
  • Experience with relevant technologies such as flow cytometry, ELISA, cell counter,qPCR, RT-PCR methods, endotoxin, sterility testing (e.g..  BacT/Alert).
  • Experience and successful track record of method transfer/verification/qualification/validation, routine testing in QC environment.
  • Knowledge related to scientific data analysis applications such as GraphPad Prism, FlowJo/FACSDiva, Novocyte, Spotfire, and JMP software packages.
  • Excellent technical writing experience in a regulatory environment (such as protocols, reports, and SOPs).
  • Implements "best practices" or leading-edge quality standards.
  • Project Management skills, including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.
  • Experience in IND, NDA and BLA submission is highly preferred.
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
  • Highly effective written and oral communication skills to address a wide variety of audiences and governing bodies.
  • Demonstrated resilience, diplomacy, influence, relationship-building, and problem-solving skills in a variety of situations.
  • Someone who leads by example

 

COMPENSATION

At Turnstone, we prioritize the well-being and success of our team. Join us and enjoy a competitive compensation package, including a base salary and performance-based bonuses. Our comprehensive benefits include:

 

  • 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.