Senior Analytical Development Scientist - Cell Therapy

Orca-Bio; California; On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical insurance

Dental insurance

Vision insurance

PTO

401(k)

Parental leave

Lunch on site

Job summary

Orca Bio is seeking an experienced analytical development scientist to own potency characterization, method development, and release testing for cell therapy programs. You will author CMC analytical content for BLA submissions and support commercialization efforts, collaborating closely with Process Development, Manufacturing, QC, and QA teams.

The ideal candidate has hands-on experience with flow cytometry, cell‑based assays, and validating methods through transfer, with a strong track record

Qualifications

• Substantial expertise in flow cytometry and cell‑based assay technologies.
• Experience with immune functional assays in cell therapy and/or biologics analytical development or quality control laboratories.
• Working knowledge of QC and cGMP requirements for the biopharmaceutical industry, including USP methodologies and ICH guidelines.
• Experience leading cross‑functional teams (CMC, clinical development).
• Strong written and verbal communication skills.

Responsibilities

• Develop and optimize multiparametric flow cytometry and cell‑based functional assays for cell therapy products.
• Lead validation of analytical methods for release and stability testing, including writing and reviewing protocols and reports.
• Drive method transfers between labs, including transfer plans, protocols, testing, and reports.
• Perform extended characterization of product, including activity, potency, and mechanism of action studies.
• Support analytical comparability and product stability studies.
• Prepare and present data summaries to stakeholders and cross‑functional teams.
• Author CMC analytical content for BLA submissions and commercial launch preparation.

Skills

Flow cytometry

Cell-based assays

Cross-functional collaboration

QC / cGMP knowledge

Regulatory documentation

Education

PhD in Pharmaceutical Sciences, Biology, Immunology, or Cell Biology

MS with outstanding track record

Tools

Regulatory writing

Job description

Orca Bio is seeking an experienced analytical development scientist to own potency characterization, method development, and release testing for cell therapy programs. You will author CMC analytical content for BLA submissions and support commercialization efforts, collaborating closely with Process Development, Manufacturing, QC, and QA teams.

The ideal candidate has hands-on experience with flow cytometry, cell‑based assays, and validating methods through transfer, with a strong track record