Associate Director, Cell Therapy Analytical Quality Team

Company: AstraZeneca GmbH
Location: Gaithersburg
Posted on: October 24, 2024

Job Description:

Associate Director, Cell Therapy Analytical Quality TeamGaithersburg, MDJoin our Oncology R&D group as an Associate Director, Cell Therapy Analytical Quality Team. The selected candidate will lead the Analytical Quality Testing group, responsible for analytical testing and support of clinical stage cell therapy products in accordance with GMP regulations. This includes management of lot release and stability programs, critical reagents, analytical tech transfer, and sample chain of custody. The team engages with analytical development and several cross-functional teams including clinical, regulatory, QA, and manufacturing.Accountabilities:

• Work collaboratively within the cell therapy technical operations (CTTO) group to manage the analytical GMP function.
• Ensure that the analytical GMP laboratory is efficient and compliant with regulatory, industry, and AstraZeneca standards.
• As a key member of the CTTO analytical sciences team, provide strategic direction to ensure GMP compliance is met in all analytical activities.
• Lead and develop a team of scientists responsible for GMP lot release and stability testing, management of critical reagent and stability-related activities, sample chain of custody, and analytical tech transfer.
• Drive lot release activities to maintain short vein-to-vein times.
• Represent the analytical GMP function in cross-functional leadership team meetings related to manufacturing, analytical development, compliance, and lot release.
• Author, review, and approve SOPs, protocols, reports, and other relevant documentation.
• Represent CTTO Analytical Sciences during regulatory and internal inspections.
• Work collaboratively with the Analytical Development team to ensure that analytical methods are appropriate and meet current regulatory requirements.Essential Skills/Experience:
  • BS/MS/PhD in Cell or Molecular Biology, Immunology, Biological Sciences, Biotechnology, Biochemistry, or related field. Experience: B.S. with 14+ years of experience, M.S. with 12+ years of experience, or Ph.D. with 6+ years of experience.
  • Prior experience managing a Quality Control or GMP testing laboratory and knowledge of cGMP and regulatory requirements for cell-based products, particularly CAR T-cells.
  • Demonstrated ability to lead a team responsible for multiple project activities and ability to set the proper priorities to implement them effectively.
  • Expertise with methods and techniques for analysis of cell therapy products, such as: Flow Cytometry, ELISA, qPCR, dPCR, cell culture, cell count and viability measurement, and cytotoxicity assays.
  • Excellent written and verbal communication skills in a cross-functional environment.
  • Demonstrated ability to make decisions under pressure that balance patient safety, compliance, and supply.
  • Confirmed critical thinking skills.
  • Strong interpersonal skills and demonstrated ability to effectively work across a large organization.Desirable Skills/Experience:
    • Prior experience performing/leading analytical testing of multiple products with short turn-around times.
    • Experience with cell therapy regulatory inspections.
    • Experience with Labware Laboratory Information System (LIMS).Ready to make a meaningful difference? Apply now and join us in our mission to eliminate cancer as a cause of death!If you're curious to know more, please contact Bobbi Poole, our Talent Acquisition Partner.Closing Date: October 8, 2024Competitive remuneration and benefits applyWe offer a competitive Total Reward program including a market-driven base salary, bonus, and long-term incentive. We have a generous paid time off program and a comprehensive benefits package.
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Keywords: AstraZeneca GmbH, Wheaton-Glenmont , Associate Director, Cell Therapy Analytical Quality Team, Executive , Gaithersburg, Maryland