Principal Scientist, CMC Analytical Development - Commercial Products
Denali Therapeutics
August 25, 2026
Remote friendly (South San Francisco, CA)
United States
Operations
Key Responsibilities
- Provide technical analytical review and approval of CMO manufacturing documents for routine commercial production.
- Assess and approve change controls impacting analytical methods, specifications, reference standards, and QC testing processes.
- Serve as analytical SME for manufacturing deviations and QC investigations (OOS/OOT, atypical results), including root cause assessment and CAPA evaluation.
- Monitor method and process performance trends at the CMO to identify risks to commercial supply or product quality.
- Provide technical review and approval of APQR in collaboration with Quality.
- Ensure continuous compliance of methods and control strategies with current industry guidelines (ICH, Pharmacopeia, FDA/EMA guidance) and best practices.
Analytical Method Transfer – In-Country Testing & International Registration
- Own and oversee analytical method transfer to support in-country/regional testing requirements for new international marketing approvals.
- Develop/execute method transfer risk assessments, protocols, acceptance criteria, and transfer reports with receiving laboratories.
- Coordinate with Regulatory Affairs, CMC, and QA to align transfer timelines with global submission and launch schedules.
- Ensure consistency of methods/specifications across sites and support harmonization where appropriate.
Global Health Authority Support
- Provide analytical/CMC technical expertise responding to health authority questions.
- Draft/review technical responses to requests related to analytical methods, specifications, validation, and control strategy.
Minimum Qualifications
- BS/MS/PhD in Chemistry, Chemical Engineering, Analytical Chemistry, Biochemistry, or related field (PhD 10+ years; MS/BS 14+ years).
- Recognized analytical/technical SME with independent judgment on complex problems.
- Hands-on biologics analytical methods experience (potency/enzymatic activity assays, ELISA, HPLC/UPLC, capillary electrophoresis, mass spectrometry, glycan analysis) for protein/enzyme-Fc fusion products.
- Commercial (post-approval) biologics manufacturing experience: batch record review, change control, QC deviation/investigation support (OOS/OOT root cause, CAPA).
- Analytical method transfer and method validation/qualification (ICH Q2) and technical transfer documentation.
- Knowledge of global regulatory requirements; experience supporting health authority interactions/submissions (FDA, EMA, others).
- Experience overseeing external CMOs/contract testing laboratories.
- Strong written/verbal communication; ability to author defensible technical/regulatory documentation.
- Travel domestically/internationally as needed.
Preferred Qualifications
- Enzyme replacement therapies, Fc-fusion proteins, or rare disease biologics experience.
- Accelerated approval/expedited regulatory pathway experience.
- Familiarity with ex-US/ex-EMA health authority expectations.
- Experience with pre-approval inspections (PAI) or health authority audits.
- Experience managing multiple external manufacturing/testing sites.
Application Instructions
- Learn more at https://www.denalitherapeutics.com/careers.
- Provide technical analytical review and approval of CMO manufacturing documents for routine commercial production.
- Assess and approve change controls impacting analytical methods, specifications, reference standards, and QC testing processes.
- Serve as analytical SME for manufacturing deviations and QC investigations (OOS/OOT, atypical results), including root cause assessment and CAPA evaluation.
- Monitor method and process performance trends at the CMO to identify risks to commercial supply or product quality.
- Provide technical review and approval of APQR in collaboration with Quality.
- Ensure continuous compliance of methods and control strategies with current industry guidelines (ICH, Pharmacopeia, FDA/EMA guidance) and best practices.
Analytical Method Transfer – In-Country Testing & International Registration
- Own and oversee analytical method transfer to support in-country/regional testing requirements for new international marketing approvals.
- Develop/execute method transfer risk assessments, protocols, acceptance criteria, and transfer reports with receiving laboratories.
- Coordinate with Regulatory Affairs, CMC, and QA to align transfer timelines with global submission and launch schedules.
- Ensure consistency of methods/specifications across sites and support harmonization where appropriate.
Global Health Authority Support
- Provide analytical/CMC technical expertise responding to health authority questions.
- Draft/review technical responses to requests related to analytical methods, specifications, validation, and control strategy.
Minimum Qualifications
- BS/MS/PhD in Chemistry, Chemical Engineering, Analytical Chemistry, Biochemistry, or related field (PhD 10+ years; MS/BS 14+ years).
- Recognized analytical/technical SME with independent judgment on complex problems.
- Hands-on biologics analytical methods experience (potency/enzymatic activity assays, ELISA, HPLC/UPLC, capillary electrophoresis, mass spectrometry, glycan analysis) for protein/enzyme-Fc fusion products.
- Commercial (post-approval) biologics manufacturing experience: batch record review, change control, QC deviation/investigation support (OOS/OOT root cause, CAPA).
- Analytical method transfer and method validation/qualification (ICH Q2) and technical transfer documentation.
- Knowledge of global regulatory requirements; experience supporting health authority interactions/submissions (FDA, EMA, others).
- Experience overseeing external CMOs/contract testing laboratories.
- Strong written/verbal communication; ability to author defensible technical/regulatory documentation.
- Travel domestically/internationally as needed.
Preferred Qualifications
- Enzyme replacement therapies, Fc-fusion proteins, or rare disease biologics experience.
- Accelerated approval/expedited regulatory pathway experience.
- Familiarity with ex-US/ex-EMA health authority expectations.
- Experience with pre-approval inspections (PAI) or health authority audits.
- Experience managing multiple external manufacturing/testing sites.
Application Instructions
- Learn more at https://www.denalitherapeutics.com/careers.