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Principal Scientist, Quality Operations

2 months ago

California, United States Turnstone Biologics Full time

We are looking for a dynamic, self-driven, and adaptable professional to take on the role of Senior Scientist, QC within our Quality division. This pivotal position is dedicated to the qualification and validation of methods, lifecycle management of methodologies, and providing technical assistance to external manufacturing partners. Responsibilities include supporting method transfers, optimizing methodologies, authoring technical documents, assessing IND support impacts, conducting laboratory investigations, and monitoring data trends.

KEY RESPONSIBILITIES

  • Collaborate with Analytical Development to devise and execute a QC method qualification and validation strategy, ensuring accountability and responsibility among key stakeholders.
  • Conduct technical reviews and approve protocols and reports related to method qualification/validation, transfer, and stability.
  • Oversee the technical review and approval of executed test methods at the external manufacturing sites, ensuring compliance with process and regulatory standards.
  • Facilitate accurate and timely documentation supporting various Quality records, including laboratory investigations, deviations, impact assessments, CAPAs, and change controls.
  • Provide hands-on technical assistance for laboratory investigations, deviations, and non-conformance events, ensuring batch disposition decisions are grounded in sound technical reasoning.
  • Engage in cross-functional teams to support, execute, and oversee method optimization, extended characterization, troubleshooting, and qualification/validation processes.
  • Develop, revise, review, approve, and maintain 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 required.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

  • Bachelor's or Master's degree with substantial experience in cell therapy, immunology, cancer biology, or a related field, along with 7+ years of industry experience, ideally in gene and cell therapy.
  • Familiarity with various phases of drug development.
  • Proficiency in relevant 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 leading-edge quality standards and best practices.
  • Project management capabilities, including resource management and issue escalation to project leads and management.
  • Experience with IND, NDA, and BLA submissions is highly desirable.
  • Able 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 responsibilities beyond the initial job description.
  • Strong organizational, written, and verbal communication skills to engage with diverse audiences and governing bodies.
  • Demonstrated resilience, diplomacy, influence, relationship-building, and problem-solving abilities.
  • Lead by example to promote the culture at Turnstone Biologics.
  • 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. 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.