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.
10 days ago