Senior Quality Control Scientist

2 weeks ago

California, United States Turnstone Biologics Full time

We are looking for a dynamic, proactive, and adaptable professional to take on the role of Senior Scientist, QC within our Quality division. This pivotal position emphasizes method qualification and validation, lifecycle management of methodologies, and providing technical support to external manufacturing partners. Responsibilities include facilitating method transfer, optimizing procedures, authoring technical documents, assessing IND support impacts, conducting laboratory investigations, and monitoring data trends.

KEY RESPONSIBILITIES

  • Collaborate with Analytical Development to devise and execute QC method qualification and validation strategies, ensuring accountability and responsibility in implementing detailed plans with key stakeholders.
  • Conduct technical reviews and approvals of method qualification/validation protocols, transfer protocols, and stability reports.
  • Ensure that executed test methods at external manufacturing sites align with Turnstone's process and regulatory standards through thorough technical review and approval.
  • Support accurate and timely documentation for various Quality records, including laboratory investigations, deviations, impact assessments, CAPAs, and change controls.
  • Provide hands-on technical assistance during laboratory investigations, deviations, and non-conformance events, ensuring batch disposition decisions are based on sound technical reasoning.
  • Engage in cross-functional collaboration 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 that emphasizes 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, preferably in gene and cell therapy.
  • Familiarity with various phases of drug development.
  • Proficient in relevant technologies, including flow cytometry, ELISA/ELLA, cell counting, qPCR, ddPCR methods, 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 such as GraphPad Prism, FlowJo, FACSDiva, Novocyte, Spotfire, and JMP software.
  • Strong technical writing skills in a regulatory context, including the preparation of protocols, reports, and SOPs.
  • Experience in implementing best practices and leading-edge quality standards.
  • Project management capabilities, including resource management and issue escalation 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 according to shifting priorities.
  • Self-driven, detail-oriented, and open to taking on temporary responsibilities beyond the initial job description.
  • Exceptional organizational, written, and verbal communication skills to engage with diverse audiences and governing bodies.
  • Demonstrated resilience, diplomacy, influence, relationship-building, and problem-solving abilities in various contexts.
  • 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.

  • Senior Scientist, Analytical Quality

    7 days 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 emphasizes method qualification and validation, lifecycle management of methods, and providing technical support to external manufacturing partners. The role includes facilitating...

  • 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...

  • Senior Scientist, Quality Assurance Operations

    7 days 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 emphasizes method qualification and validation, lifecycle management of methods, and providing technical support to external manufacturing partners. Responsibilities include method...

  • Senior Formulation Scientist

    1 day ago

    California, United States HireMinds Full time

    Job SummaryWe are seeking a highly experienced Senior Scientist, Formulation to lead our efforts in solid oral formulation and process development. As a key member of our team, you will play a critical role in advancing the pharmaceutical development of oral dosage forms, providing both scientific and technical expertise in formulating drugs for clinical...

  • Lead Scientist, Quality Assurance

    7 days 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...

  • Principal Scientist, Quality Operations

    7 days 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...

  • Senior Research Scientist in AI

    2 weeks ago

    California, United States Storm3 Full time

    Senior Research Scientist in AIInnovative Biotech Company Focused on LLMs for Life SciencesLocation: San Francisco Bay Area, USACompensation: $250,000 - $300,000 plus bonuses and equityWe are seeking a highly skilled Senior Research Scientist to contribute to a pioneering biotech initiative aimed at developing the most comprehensive and precise family of...

  • Senior Research Scientist

    1 week ago

    California, United States NeuralRec Full time

    About the RoleWe are seeking a highly skilled Senior Research Scientist to join our team at NeuralRec. As a key member of our research team, you will be responsible for leading the development of our internal Large Language Model (LLM) platform.Key Responsibilities:Develop and lead a small research team to advance our LLM platformCollaborate with the wider...

  • Lead Scientist in Process Innovation

    2 weeks ago

    California, United States EPM Scientific Full time

    Lead Scientist - Process Innovation & DevelopmentJoin a dynamic team focused on advancing biopharmaceutical processes.Compensation: Competitive salary along with an attractive bonus and benefits package.Key Responsibilities:Direct upstream process innovation, downstream operations, and engineering solutions.Manage internal processes and collaborate with both...

  • Lead Scientist in Process Innovation

    2 weeks ago

    California, United States EPM Scientific Full time

    Principal Scientist - Process Development & ManufacturingLocation: Greater LA AreaCompensation: Competitive salary with exceptional bonus and benefits packageKey Responsibilities:Direct upstream process innovation, downstream operations, and engineering solutionsManage internal activities and coordinate with domestic and international partnersProvide...

  • Senior Quantum Sensing Scientist

    2 weeks ago

    California, Missouri, United States Northrop Grumman Full time

    Join Northrop Grumman as a Senior Quantum Sensing Scientist At Northrop Grumman, we provide our employees with remarkable opportunities to contribute to groundbreaking systems that influence lives globally, both now and in the future. Our innovative and adventurous spirit has positioned us at the leading edge of numerous technological breakthroughs in our...

  • Quality Control Analytical Scientist

    2 weeks ago

    Camarillo, California, United States Eurofins USA PSS Insourcing Solutions Full time

    Job Overview:This position is situated within the Quality Control Department, focusing on the support of method transfers and validations, in addition to conducting release and stability assessments for large-molecule clinical and commercial projects.Key Responsibilities:Conduct ELISA assays with precision.Utilize and execute wet-lab instrumentation and...

  • Food Scientist

    3 weeks ago

    California, United States Client Full time

    Food Scientist$75,000 - $95, weeks Holiday + Bonus + Training + Career Progression + 401K + Medical, Dental, Vision (80% Coverage) + Life Insurance + More BenefitsSanta Barbara, California Are you a Food Scientist looking for a technically varied, highly innovative position working for an ambitious manufacturing organization operating at the forefront of...

  • Senior Clinical Research Scientist

    1 week ago

    California, United States EPM Scientific Full time

    Job SummaryEPM Scientific is seeking a highly experienced Clinical Scientist to join our team. As a Clinical Scientist, you will be responsible for leading clinical research studies and ensuring the highest level of quality and compliance.Key ResponsibilitiesDesign and implement clinical research studies, including protocol development and study...

  • Senior Research Scientist in AI and Life Sciences

    7 days ago

    California, United States Storm3 Full time

    Senior Research Scientist - AI and Life SciencesFocus on LLM and Foundation Models in BiotechLocation: San Francisco Bay Area, USACompensation: $250,000 - $300,000 plus bonus and equityWe are seeking a highly skilled Senior Research Scientist to contribute to an innovative biotech company dedicated to developing the most comprehensive and precise family of...

  • Senior Research Associate, Quality Control

    2 months ago

    California, United States Insmed Incorporated Full time

    Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are...

  • Senior Scientist II

    4 days ago

    California, United States Meet Full time

    Job SummaryWe are seeking a highly skilled Senior Scientist II to join our team at Meet, a leading biotech company in the Oncology space. As a key member of our formulation development team, you will be responsible for driving science-based formulation development and strategy for small molecule projects from first-in-human formulations to commercial...

  • Senior Scientist II

    4 days ago

    California, United States Meet Full time

    Job SummaryWe are seeking a highly skilled Senior Scientist II to join our team at Meet, a leading biotech company in the Oncology space. As a key member of our formulation development team, you will be responsible for driving science-based formulation development and strategy for small molecule projects from first-in-human formulations to commercial...

  • Senior Clinical Research Scientist

    2 days ago

    South San Francisco, California, United States Biogen Full time

    Job SummaryBiogen is seeking a highly experienced Principal Clinical Scientist to support clinical research activities for our portfolio of immunology clinical programs. The successful candidate will provide leadership in program development, execution, innovation, and optimization of clinical trials by incorporating the latest insights on disease...

  • Senior Clinical Research Scientist

    1 hour ago

    South San Francisco, California, United States Biogen Full time

    About This RoleBiogen is seeking a highly skilled Principal Clinical Scientist to support clinical research activities for our portfolio of immunology clinical programs, with a specific emphasis on severe immune-mediated diseases related to transplantation.This position provides leadership in program development, execution, innovation, and optimization of...