{"id":2484573,"url":"https://alion.io/job/orca-bio-senior-principal-scientist-cmc-analytical-development","title":"Senior / Principal Scientist, CMC Analytical Development","company":{"id":4299,"name":"Orca Bio","domain":"orcabio.com","url":"https://alion.io/company/orca-bio","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"B","score":80,"open_postings":13,"ghost_share":0,"stale_share":0.615,"repost_share":0,"time_to_fill_p50_days":75,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Sacramento, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":120000,"max":170000,"currency":"USD","period":"year","gross":null,"usd_annual":170000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Flow Cytometry","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-13T20:58:35Z","employer_posted_date":"2026-10-13","last_verified_at":"2026-11-01T07:22:03Z","board_verified":true,"closed_at":null,"days_open":18,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":18},"description":"Summary:\nIn 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.\nKey Responsibilities\nMethod Development, Validation & Transfer\nDevelop and optimize multiparametric flow cytometry and cell-based functional assays for cell therapy products.\nLead validation of analytical methods for release and stability testing, including writing and reviewing protocols and reports.\nDrive method transfers between sending and receiving labs, including the overall transfer plan, protocols, execution of transfer testing, and reports.\nCharacterization, Potency & Mechanism of Action\nPerform extended characterization of product, including biological activity, potency, and mechanism of action studies.\nSupport analytical comparability and product stability studies.\nInterpret experimental results and perform data analysis using appropriate software.\nServe as subject matter expert for one or more analytical technologies such as flow cytometry, bioassays, cell counting, particle testing, or potency methods.\nRegulatory & Commercialization\nAuthor 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.\nAuthor and review protocols, technical reports, method SOPs, and regulatory submission sections.\nCollaboration & Communication\nPartner with Process Development, Manufacturing, QC, QA and other teams.\nPrepare and present data summaries and project updates to stakeholders and at cross-functional team meetings.\nRequired Qualifications\nEducation & Experience\nPhD in Pharmaceutical Sciences, Biology, Immunology, Cell Biology, or a related field with 5-8+ years of relevant industry experience.\nM.S. candidates may be considered with an outstanding track record in analytical development and the drug product process development.\nTechnical Expertise and Core Skills\nSubstantial expertise in flow cytometry and cell-based assay technologies.\nExperience with immune functional assays in cell therapy and/or biologics analytical development or quality control laboratories.\nWorking knowledge of QC and cGMP requirements for the biopharmaceutical industry, including relevant USP methodologies and ICH guidelines.\nExperience working with and leading cross-functional teams, such as CMC and clinical development teams.\nStrong written and verbal communication skills.\nSelf-starter with strong interpersonal, planning, and tracking skills.\nAbility to manage multiple competing priorities in a fast-paced, changing environment.\nPreferred Qualifications:\nHistory with commercialization projects and a successful track record of BLA or IND authorship.\nExperience in cGMP cell therapy and/or biological product manufacturing, particularly with immunological systems, cell therapy, gene therapy, or individualized patient therapies.\nExpertise in flow cytometry assay development and validation","description_format":"text","description_chars":3443,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-13T23:58:33Z"}],"visa":[],"liveness":{"score":60,"band":"ok","label":"Likely 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