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Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve outcomes for patients with blood cancer, addressing the limitations of traditional allogeneic stem cell transplants. The company operates a state-of-the-art 100,000-square-foot manufacturing facility in Sacramento, CA.
As Senior Scientist in CMC Analytical Development, you will lead the development, optimization, and validation of analytical methods for cell therapy products. Your responsibilities span three core areas:
**Method Development & Validation:** Develop and optimize multiparametric flow cytometry and cell-based functional assays. Lead validation of analytical methods for release and stability testing, including protocol and report authorship. Drive method transfers between labs, managing transfer plans, execution, and documentation.
**Characterization & Potency:** Perform extended product characterization including biological activity, potency, and mechanism of action studies. Support analytical comparability and stability studies. Interpret experimental results and perform data analysis. Serve as subject matter expert for analytical technologies such as flow cytometry, bioassays, cell counting, particle testing, or potency methods.
**Regulatory & Commercialization:** Author CMC analytical content for BLA submissions and commercial launch, including specifications, method development/validation, potency studies, comparability, and stability data. Author and review protocols, technical reports, method SOPs, and regulatory submission sections.
**Collaboration:** Partner cross-functionally with Process Development, Manufacturing, QC, QA, and clinical teams. Prepare and present data summaries and project updates to stakeholders.
This role offers the opportunity to directly impact patient outcomes by ensuring the analytical rigor and regulatory compliance of life-saving cell therapies at a company with a strong scientific mission and entrepreneurial culture.
**Requirements:**
- PhD in Pharmaceutical Sciences, Biology, Immunology, Cell Biology, or related field with 5–8+ years of relevant industry experience (M.S. candidates considered with outstanding track record in analytical development and drug product process development)
- Substantial expertise in flow cytometry and cell-based assay technologies
- Experience with immune functional assays in cell therapy and/or biologics analytical development or QC laboratories
- Working knowledge of QC and cGMP requirements for biopharmaceutical industry, including USP methodologies and ICH guidelines
- Experience working with and leading cross-functional teams (CMC and clinical development)
- Strong written and verbal communication skills
- Self-starter with strong interpersonal, planning, and tracking skills
- Ability to manage multiple competing priorities in fast-paced, changing environment
**Preferred Qualifications:**
- History with commercialization projects and successful track record of BLA or IND authorship
- Experience in cGMP cell therapy and/or biological product manufacturing, particularly with immunological systems, cell therapy, gene therapy, or individualized patient therapies
- Expertise in flow cytometry assay development and validation
