Associate Director, Analytical Sciences - Potency & Bioassay Development

AstraZeneca seeks an Associate Director in Analytical Sciences to lead potency and bioassay development for cell and gene therapies from early development through commercialization. This scientific leadership role involves setting technical strategy, building analytical capabilities in cell-line engineering and gene editing, and supporting regulatory submissions for products advancing toward late-stage development and commercial launch.

Responsibilities

• Lead analytical strategy for potency and functional bioassays across cell therapy portfolio, defining phase-appropriate approaches
• Develop, qualify, validate, and manage cell-based potency assays including flow cytometry and reporter-based methods
• Build cell-line engineering and banking capabilities, including engineered target and reporter line design and characterization
• Drive method robustness using Quality by Design, Design of Experiments, and risk-based development approaches
• Author analytical sections of regulatory submissions from IND through BLA and mentor analytical scientists

Requirements

• PhD in Immunology, Cell Biology, Molecular Biology, Biochemistry, or Bioengineering with 6+ years relevant experience (or equivalent with advanced degree)
• Substantial analytical development experience in cell therapy, gene therapy, or biologics within regulated environments
• Proven expertise developing and qualifying cell-based potency and functional assays for QC use
• Strong knowledge of immune cell biology, specifically T-cell and NK-cell signaling mechanisms
• Hands-on experience with multiparametric flow cytometry and other cell-based analytical platforms
• Deep understanding of analytical method lifecycle: development, qualification, validation, transfer, lifecycle management
• Experience authoring analytical content for regulatory submissions and demonstrated cross-functional scientific leadership

Compensation: $138,000–$207,000 base