Senior Scientist, Quality Control (Cell Therapy)

We are seeking an innovative, self-motivated and versatile individual to join us as a Senior Scientist, QC within the Quality organization. This is a key role focused on method qualification/validation, method life-cycle management, technical support of external manufacturing partners, including supporting method transfer, method optimization, technical document authoring, IND support impact assessment, laboratory investigation, data trending 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 QC method qualification and validation strategy in collaboration with Analytical Development. Accountable and responsible for implementing the detailed method qualification and validation strategy with key stakeholders.
• Technical review and approval of method qualification/validation protocols and reports, transfer protocols and reports, and stability reports.
• Technical review and approval of executed test methods at the CDMO and ensure they meet the requirements of Turnstone’s process and regulatory guidelines.
• 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.
• Collaborate in cross-functional teams 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.
• Cultivate a team culture of high standards, collaboration, empowerment, and trust.
• Additional duties as assigned.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

• 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 different phases of drug development
• Experience with relevant technologies on flow cytometry, ELISA/ELLA, cell counter, qPCR, ddPCR 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).
• Implementation of "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 organization, written, and verbal communication skills to address a wide variety of audiences and governing bodies.
• Demonstrated resilience, diplomacy, influence, relationship-building, and problem-solving skills in various situations.
• Leads by example to foster Turnstone Biologics culture.
• Occasional travel to support cross-functional workshops or strategy/planning activities

COMPENSATION/BENEFITS

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.