Director, Analytical Development (Flow Cytometry & Method Validation)

Summary:

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.

Responsibilities

Leadership & Strategy

• 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.

Flow Cytometry & Cell Therapy Expertise

• 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.

Analytical Method Development & Validation

• Oversee development, qualification, transfer, and ICH-compliant validation of analytical methods.
• Ensure assays meet regulatory expectations for precision, accuracy, specificity, robustness, and stability.
• Lead comparability studies, reference standard programs, and method lifecycle management.
• Establish an efficient strategy for method validation and transfer.

Regulatory & Compliance

• Author and review analytical sections of IND, BLA, and other regulatory submissions.
• Serve as a technical subject matter expert during regulatory agency interactions.
• Ensure compliance with cGMP, GLP, and regulatory guidelines.

Operational Excellence

• Drive continuous improvement in assay robustness, throughput, and scalability.
• Manage budgets, timelines, and resource allocation across multiple programs.
• Oversee technology transfer to Quality Control laboratories.

Required Qualifications

Education & Experience

• Ph.D. in Immunology, Cell Biology, Analytical Chemistry, or related field required
• Minimum 10+ years of industry experience in biotech or pharma
• 8+ years’ experience in experience in cell therapy analytical development (e.g., CAR-T, gene-modified cells, stem cells)
• MSc degree acceptable with 15+ years of relevant experience

Technical Expertise

• Deep expertise in flow cytometry assay development (multicolor panels, intracellular staining, rare cell detection, functional assays)
• Strong background in analytical method validation (ICH Q2 and regulatory expectations)
• Experience with cell-based potency assays
• Familiarity with advanced cytometry technologies (e.g., spectral cytometry, CyTOF) is a plus
• Strong understanding of CMC development for biologics and cell therapies

Leadership Skills

• Proven experience leading and developing high-performing teams
• Strong project management and cross-functional leadership skills
• Ability to influence stakeholders at all organizational levels
• Strategic thinking and scientific rigor
• Strong communication and presentation skills
• Results-driven with a focus on quality and compliance
• Ability to manage complexity in a fast-paced environment

Preferred Qualifications

• Experience supporting late-stage clinical programs or commercial products
• Prior experience interacting with FDA/EMA regulatory agencies
• Experience in data analysis tools (FlowJo or equivalent)
• Knowledge of automation and digital data systems in analytical labs