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.
ResponsibilitiesLeadership & 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 QualificationsEducation & 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
$175,000 - $215,000 a year
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
