Lead Scientist, Quality Assurance

1 week ago

California, United States Turnstone Biologics Full time

We are looking for a dynamic, proactive, and adaptable professional to join our team as a Senior Scientist in Quality Control within the Quality department. This pivotal position is centered on method qualification and validation, lifecycle management of methodologies, and providing technical support to external manufacturing partners. Responsibilities include facilitating method transfer, optimizing processes, authoring technical documents, assessing IND support impacts, conducting laboratory investigations, and monitoring data trends.

KEY RESPONSIBILITIES

  • Collaborate in the development and execution of QC method qualification and validation strategies alongside Analytical Development, ensuring accountability and engagement with key stakeholders.
  • Conduct technical reviews and approvals of method qualification and validation protocols, transfer protocols, and stability reports.
  • Ensure that executed test methods at external manufacturing sites comply with the established process and regulatory standards.
  • Support accurate and timely documentation for various Quality records, including laboratory investigations, deviations, impact assessments, CAPAs, and change controls.
  • Provide direct technical assistance during laboratory investigations, deviations, and non-conformance events, ensuring that batch disposition decisions are based on sound technical principles.
  • Engage in cross-functional collaborations to support and oversee method optimization, extended characterization, troubleshooting, and qualification/validation efforts.
  • Develop, revise, review, and approve Standard Operating Procedures (SOPs) and technical protocols/reports.
  • Assist in data review and contribute to product and assay control trending and monitoring.
  • Foster a team culture characterized by high standards, collaboration, empowerment, and trust.
  • Perform additional duties as assigned.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

  • Bachelor's or Master's degree with substantial experience in cell therapy, immunology, cancer biology, or a related field, coupled with over 7 years of industry experience, ideally in gene and cell therapy.
  • Familiarity with various phases of drug development.
  • Proficient in technologies such as flow cytometry, ELISA/ELLA, cell counting, qPCR, ddPCR, endotoxin, and sterility testing.
  • Proven track record in method transfer, verification, qualification, validation, and routine testing within a QC environment.
  • Knowledge of scientific data analysis tools, including GraphPad Prism, FlowJo, FACSDiva, Novocyte, Spotfire, and JMP software.
  • Exceptional technical writing skills in a regulatory context, including protocols, reports, and SOPs.
  • Experience in implementing best practices and leading-edge quality standards.
  • Strong project management capabilities, including resource management and issue escalation.
  • Experience with IND, NDA, and BLA submissions is highly advantageous.
  • Able to thrive in a fast-paced environment with minimal supervision and adapt to shifting priorities.
  • Self-driven, detail-oriented, and open to taking on responsibilities beyond the initial job description.
  • Excellent organizational, written, and verbal communication skills to engage with diverse audiences and governing bodies.
  • Demonstrated resilience, diplomacy, influence, relationship-building, and problem-solving abilities.
  • Exemplifies Turnstone Biologics' culture through leadership.
  • Willingness to travel occasionally for cross-functional workshops or strategic 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.

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