Director, Potency Assay Development- Analytical Operations

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Job Description

We are seeking a Director to lead our Potency Assay Development Team within Analytical Operations. The successful candidate will drive strategy and execution for potency assays supporting both cell therapy (e.g., CAR T) and gene therapy (e.g., viral vectors), including development, optimization, qualification/validation, and lifecycle management of mechanism-of-action (MOA)-relevant methods for clinical and commercial programs. This role partners closely with QC, Process Development, Manufacturing, Regulatory, and CMC to deliver assays that are fit for routine GMP release and stability testing, prioritizing robustness, control strategy, documentation, audit readiness, and to support comparability across process and site changes.

Reports to Senior Director, Analytical Development and Automation.

Responsibilities

• Lead a high-performing technical team, fostering mentorship, scientific guidance, and career development.

• Drive the development, optimization, and qualification/validation of potency assays for cell therapies (e.g., CAR T) and gene therapies (e.g., viral vectors) to support product release, stability, and characterization.

• Ensure assay robustness, reproducibility, and transferability for commercial manufacturing through fit-for-purpose design, appropriate controls/standards, and statistically sound experimental design.

• Oversee technical documentation (protocols, reports, SOPs), method validation/verification packages, and regulatory-ready content supporting potency for IND/IMPD and BLA/MAA submissions and post-approval changes.

• Apply Quality by Design (QbD) and risk-based principles to define potency assay control strategy and critical method parameters, ensuring methods are scientifically justified, appropriately controlled, and scalable from early development through commercial QC.

• Demonstrate fluency with ICH and global regulatory expectations for analytical methods (e.g., phase-appropriate validation/verification, comparability, and data integrity) and translate guidance into practical, compliant strategies for cell and gene therapy potency assays.

• Stay at the forefront of potency assay technologies for cell and gene therapies, including CAR T functional assays (e.g., cytokine release, cytotoxicity, activation/proliferation) and viral vector potency (e.g., infectivity/transduction, expression-based readouts, ddPCR), as well as emerging platforms and associated analytical methodologies.

• Provide strategic direction for potency assay selection and development (MOA alignment, assay formats, reference standards), troubleshooting, and data interpretation to support program and regulatory needs.

• Lead high-impact CMC analytical projects, ensuring potency assay timelines and deliverables support stage-appropriate development through licensure and lifecycle management.

• Embed a QC mindset in potency assay lifecycle management: enable routine release and stability execution through clear SOPs/training, system suitability and trending, and lead/support investigations (OOS/OOT/deviations), CAPA, and change control to maintain a compliant state.

• Represent Analytical Operations in internal and external collaborations (QC, CDMOs/vendor labs), leading method transfer and ensuring compliance with cGMP and relevant compendial/industry standards.

• Cultivate a culture of excellence, innovation, and cross-functional collaboration.

Basic Qualifications

Ph.D. or Advanced degree in Immunology, Cell Biology, Bioengineering, or related field with 8+ years of relevant industry experience

OR

Master’s degree in Immunology, Cell Biology, Bioengineering, or related field with 10+ years of relevant industry experience

OR

Bachelor’s degree in Immunology, Cell Biology, Bioengineeri