Associate Director, Quality Control

Kincell Bio, LLC
Durham, NC
Job Description
Kincell Bio is seeking a highly motivated Associate Director, Quality Assurance who will be a key contributor to a dynamic and collaborative Quality Assurance team. The Associate Director – Quality Control Lab will provide strategic, technical, and operational leadership for analytical quality control supporting cell therapy manufacturing.

Requirements

  • Bachelor’s Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field
  • 8+ of experience in Quality Control in a pharmaceutical manufacturing environment
  • A minimum of 3 years of management in a Quality Control laboratory
  • Direct involvement in tech transfer, method lifecycle management, and phase-appropriate analytical strategy
  • Strong experience in QC analytical testing of cell therapy, gene therapy, or biologics; CAR-T experience preferred
  • Previous experience in contract development and manufacturing organizations preferred
  • Proven ability to navigate regulatory expectations for ATMPs, including assay validation and method lifecycle management

Benefits

  • Competitive benefits
  • Challenging career opportunities
  • An environment that recognizes and rewards performance
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