Senior / Principal Scientist, CMC Analytical Development

Orca Bio•Sacramento, CA

12d

About The Position

Orca Bio is hiring a Senior / Principal Scientist to own analytical development for potency, mechanism of action, product characterization, and release testing methods supporting early- and late-stage cell therapy programs. The role includes preparing CMC analytical content for BLA submissions and helping prepare programs for commercialization. The successful candidate will be a hands-on scientist with expertise in flow cytometry and cell-based assays, experience advancing methods through validation and transfer, and the ability to work closely with Process Development, Manufacturing, QC, and Quality.

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 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.

Nice To Haves

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.

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 sending and receiving labs, including transfer plans, protocols, execution of transfer testing, and reports.
Perform extended product characterization, 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 a subject matter expert for one or more analytical technologies, such as flow cytometry, bioassays, cell counting, particle testing, or potency methods.
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.
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.