Quality Control Senior Specialist

2 weeks ago

California, United States Turnstone Biologics Full time

We are looking for a dynamic, self-driven, and adaptable professional to join our team as a Senior Scientist in Quality Control within the Quality department. This pivotal position emphasizes method qualification and validation, lifecycle management of methods, and providing technical support to external manufacturing partners. The role includes supporting method transfer, optimization, technical documentation, IND support impact assessment, laboratory investigations, and data analysis.

KEY RESPONSIBILITIES

  • Collaborate in the development and execution of QC method qualification and validation strategies alongside Analytical Development. Responsible for the implementation of detailed strategies with key stakeholders.
  • Conduct technical reviews and approve method qualification/validation protocols, transfer protocols, and stability reports.
  • Ensure that executed test methods at the external manufacturing site comply with Turnstone's processes and regulatory standards.
  • Support accurate and timely documentation related to 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 batch disposition decisions are based on sound technical reasoning.
  • Engage in cross-functional teams to support, execute, and oversee method optimization, extended characterization, troubleshooting, and qualification/validation.
  • 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 responsibilities as assigned.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

  • Bachelor's or Master's degree with proven experience in cell therapy, immunology, cancer biology, or a related field, with over 7 years of industry experience, preferably in gene and cell therapy.
  • Familiarity with various phases of drug development.
  • Experience with technologies such as flow cytometry, ELISA/ELLA, cell counters, qPCR, ddPCR methods, endotoxin, and sterility testing.
  • Demonstrated success in method transfer, verification, qualification, validation, and routine testing in a QC environment.
  • Proficient in scientific data analysis applications like GraphPad Prism, FlowJo, FACSDiva, Novocyte, Spotfire, and JMP software.
  • Strong technical writing skills in a regulatory context, including protocols, reports, and SOPs.
  • Experience implementing best practices or leading-edge quality standards.
  • Project management skills, including resource management and the ability to escalate relevant issues to project leads and management.
  • Experience with IND, NDA, and BLA submissions is highly desirable.
  • Ability to thrive in a fast-paced environment with minimal supervision and adapt workload based on shifting priorities.
  • Self-motivated, detail-oriented, and open to taking on temporary responsibilities outside of the initial job description.
  • Excellent organizational, written, and verbal communication skills to engage with diverse audiences and governing bodies.
  • Proven resilience, diplomacy, influence, relationship-building, and problem-solving abilities in various contexts.
  • Exemplify Turnstone Biologics culture through leadership.
  • Willingness to travel occasionally to support cross-functional workshops or strategic planning activities.

COMPENSATION/BENEFITS

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

  • 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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