Director, Analytical Development (Flow Cytometry & Method Validation)

Orcabiosystems; Sacramento (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical benefits

Dental benefits

Vision benefits

PTO

401(k) plan

Life insurance

Lunch and snacks on-site

Job summary

Orcabiosystems in Sacramento is seeking an accomplished leader to design, develop, validate, and manage analytical methods for cell therapy programs, with emphasis on advanced flow cytometry and method validation.

You will build and guide a high-performing scientific team, ensure regulatory readiness for IND/BLA submissions, and drive lifecycle management and technology transfer to QC.

Qualifications

• Ph.D. in immunology, cell biology, analytical chemistry, or related field.
• 10+ years of industry experience with 8+ years in cell therapy analytics.
• Experience with regulatory submissions (IND, BLA) preferred.
• Leadership experience building and leading scientific teams.

Responsibilities

• Lead analytical development strategy aligned with regulatory timelines.
• Oversee development, validation, transfer, and comparability studies.
• Mentor scientists in flow cytometry and cell-based assays.
• Collaborate with Process Development, Manufacturing, Regulatory Affairs.

Skills

Flow cytometry

Cell therapy analytics

Regulatory submissions

Leadership

Cross-functional collaboration

Project management

Data analysis (FlowJo)

Education

Ph.D. in Immunology, Cell Biology, Analytical Chemistry, or related field

MSc with 15+ years of relevant experience

Tools

FlowJo

spectral cytometry

CyTOF

Job description

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 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.

Additional Experience

• 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.

Compensation & Benefits

The anticipated annual salary range for this role is based on prior experience, location, and other factors. In addition to salary, eligible full-time employees receive pre‑IPO equity, annual bonus, 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.