Director, Analytical Development (Flow Cytometry & Method Validation)

In this Sacramento-based role, reporting into our VP/Head of CMC, you will lead the design, development, validation, and lifecycle management of analytical methods supporting cell therapy programs.

This role will provide strategic and technical leadership with a strong emphasis on advanced flow cytometry , method validation , and cell-based assays .

The ideal candidate brings deep expertise in cell therapy analytics , a proven track record in regulatory submissions, and demonstrated success in building and leading high-performing scientific teams.

• Provide scientific and operational leadership for the Analytical Development function supporting cell therapy programs.
• Build, mentor, and lead a team of scientists specializing in flow cytometry, cell-based assays, and analytical characterization.
• Define and execute analytical strategies aligned with program, regulatory, and commercialization timelines.
• Collaborate cross-functionally with Process Development, Manufacturing, Regulatory Affairs, QC, and Clinical teams.
• Develop methods related to raw material testing and microbial release tests.

• Lead the development, optimization, and qualification of multiparametric flow cytometry assays for cell identity, purity, potency, and phenotypic characterization.
• Establish standardized panels, controls, and gating strategies for complex cell therapy products (e.g., CAR-T, TCR-T, stem cell-derived therapies).
• Drive innovation in high-dimensional cytometry and data analysis approaches.