Principal Scientist, CMC Analytical Development - Commercial Products
$159,000–$207,000 year
On-siteSouth San Francisco, California, United States
Job Summary
Provide technical analytical review and approval of CMO manufacturing documents for routine commercial production and oversee analytical method transfers to support in-country testing and international registration. Serve as the analytical subject matter expert for manufacturing deviations and QC laboratory investigations, including root cause assessment and CAPA evaluation, while monitoring ongoing method and process performance trends. Draft and review technical responses to information requests from global health authorities regarding analytical methods, specifications, and control strategies. Collaborate with Regulatory Affairs, CMC, and QA to align transfer timelines with global submission schedules and ensure continuous compliance with ICH, Pharmacopeia, and FDA/EMA guidance. Partner with peer analytical leads and external CMOs to drive successful analytical transfer and registration of second-source manufacturing and QC sites.
Required Qualifications
- BS/MS/PhD in Chemistry, Chemical Engineering, Analytical Chemistry, Biochemistry, or related scientific discipline
- PhD with 10+ years or MS/BS with 14+ years of relevant industry experience
- Demonstrated track record as a recognized analytical/technical subject matter expert
- Ability to operate with a high degree of independence
- Ability to exercise sound scientific judgment on complex, ambiguous problems
- Significant hands-on experience with biologics analytical methods (e.g., potency/enzymatic activity assays, ELISA, HPLC/UPLC, capillary electrophoresis, mass spectrometry, glycan analysis) relevant to protein/enzyme-Fc fusion products
- Direct experience supporting commercial (post-approval) biologics manufacturing, including batch record review, change control, and QC deviation/investigation support (e.g., OOS/OOT root cause analysis and CAPA frameworks)
- Experience with analytical method transfer, method validation/qualification (ICH Q2), and technical transfer documentation
- Working knowledge of global regulatory requirements
- Experience supporting health authority interactions or submissions (FDA, EMA, and other international agencies)
- Experience working with and providing oversight of external CMOs/contract testing laboratories
- Strong written and verbal communication skills
- Ability to author clear, defensible technical and regulatory documentation
- Ability to travel domestically and internationally as needed
Desired Qualifications
- Experience with enzyme replacement therapies, Fc-fusion proteins, or rare disease biologics
- Experience with products launched under accelerated approval or other expedited regulatory pathways
- Familiarity with ex-US and ex-EMA health authority expectations regarding analytical and QC testing requirements
- Experience supporting pre-approval inspections (PAI) or health authority audits
- Prior experience managing multiple external manufacturing/testing sites simultaneously
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