Director, Analytical Development (Flow Cytometry & Method Validation)

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.

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.

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.

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

• 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