Orca Bio

Director, Analytical Development (Flow Cytometry & Method Validation)

Sacramento, CA · Director · Full-time

Sponsorship not specified$175k-$215kDetected 36 days ago

Data AnalysisProject ManagementGMPFDA RegulatoryFlow CytometryLeadershipCommunicationRegulatory Affairs

About the role

More than one million people in the United States today are fighting blood cancer.
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.

Build, mentor, and lead a team of scientists specializing in flow cytometry, cell-based assays, and analytical characterization.
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.
Drive innovation in high-dimensional cytometry and data analysis approaches.
Lead comparability studies, reference standard programs, and method lifecycle management.
Drive continuous improvement in assay robustness, throughput, and scalability.
Manage budgets, timelines, and resource allocation across multiple programs.
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.

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)
Experience with cell-based potency assays
Strong understanding of CMC development for biologics and cell therapies
Ability to influence stakeholders at all organizational levels

We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity.
Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn't been paved.
We aren't afraid to ask "why not" and challenge the status quo.
Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening.
Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only.
We do not accept unsolicited resumes, and we rarely outsource recruitment.

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.

We are driven by a passion for science and compassion for patients.
We embrace an entrepreneurial spirit and take calculated risks to achieve our mission.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

This listing is sourced directly from Orca Bio's careers page and normalized into a canonical job model.