Senior / Principal Scientist, CMC Analytical Development
Orca Bio
Summary
In this role, you will own analytical development for potency, mechanism of action, product characterization, and release testing methods supporting early- and late-stage cell therapy programs. You will also author CMC analytical content for BLA submissions and help prepare our programs for commercialization. The ideal candidate is a hands-on, seasoned scientist with strong flow cytometry and cell-based assay expertise, experience taking methods through validation and transfer, and a track record of working closely with Process Development, Manufacturing, QC, and Quality.
Job description
Key Responsibilities
Method Development, Validation & Transfer
- 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 sending and receiving labs, including the overall transfer plan, protocols, execution of transfer testing, and reports.
Characterization, Potency & Mechanism of Action
- Perform extended characterization of product, including biological activity, potency, and mechanism of action studies.
- Support analytical comparability and product stability studies.
- Interpret experimental results and perform data analysis using appropriate software.
- Serve as subject matter expert for one or more 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 preparation, including specifications, method development and validation, potency and mechanism of action studies, comparability, and stability.
- Author and review protocols, technical reports, method SOPs, and regulatory submission sections.
Collaboration & Communication
- Partner with Process Development, Manufacturing, QC, QA and other teams.
- Prepare and present data summaries and project updates to stakeholders and at cross-functional team meetings.
Requirements
- PhD in Pharmaceutical Sciences, Biology, Immunology, Cell Biology, or a related field with 5-8+ years of relevant industry experience.
- M.S. candidates may be considered with an outstanding track record in analytical development and the 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 quality control laboratories.
- Working knowledge of QC and cGMP requirements for the biopharmaceutical industry, including relevant USP methodologies and ICH guidelines.
- Experience working with and leading cross-functional teams, such as CMC and clinical development teams.
- Strong written and verbal communication skills.
- Self-starter with strong interpersonal, planning, and tracking skills.
- Ability to manage multiple competing priorities in a fast-paced, changing environment.
- History with commercialization projects and a 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
Benefits
- Pre-IPO equity
- Annual bonus
- Medical, Dental & Vision
- PTO
- 401(k) plan
- Life insurance
- Accidental death and disability coverage
- Parental leave
- Subsidized daily lunches
- Snacks
Company overview
Orca Bio is a late-stage biotechnology company headquartered in Menlo Park, California, specializing in the development of high-precision cell therapies for the treatment of blood cancers and autoimmune diseases. Founded in 2016, the company focuses on creating allogeneic T-cell immunotherapies designed to replace a patient's diseased blood and immune system with a healthy one. Their proprietary manufacturing platform utilizes single-cell precision to develop uniquely-defined cell therapy products that aim to revolutionize the field of allogeneic cell therapy. Orca Bio's lead investigational product, Orca-T, is currently in advanced clinical development for hematological malignancies including acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and myelodysplastic syndrome (MDS). The company employs a team of leading scientists, engineers, and clinicians who are united in their mission to transform patient lives through innovative cell therapy approaches that offer the promise of a cure without compromise.