Director, Analytical Development (Flow Cytometry & Method Validation)

Orca Bio•Sacramento, CA

6d•Onsite

About The Position

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. 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.

Requirements

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
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
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

Nice To Haves

Familiarity with advanced cytometry technologies (e.g., spectral cytometry, CyTOF) is a plus
Strong understanding of CMC development for biologics and cell therapies
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

Responsibilities

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.
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.
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.
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.