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Sacramento, California, United States · On-site
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Grass Valley, California, United States · On-site
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Chico, California, United States · On-site
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Downey, California, United States · On-site
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Los Angeles, California, United States · On-site
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Chico, California, United States · On-site
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La Mesa, California, United States · On-site
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Oceanside, California, United States · On-site
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San Diego, California, United States · Remote OK
$22/hr–$33/hr
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South San Francisco, California, United States • On-site
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The Principal Scientist will serve as the Commercial Analytical Lifecycle Lead, providing technical oversight for commercial manufacturing, QC activities, and analytical method transfers. They will also lead international registration efforts and collaborate with cross-functional teams to ensure global regulatory compliance and uninterrupted product supply.
Candidates must hold a PhD with 10+ years or a BS/MS with 14+ years of relevant industry experience in a scientific discipline. Strong expertise in biologics analytical methods, commercial manufacturing support, and global regulatory requirements is essential.
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
Key Responsibilities
Commercial Manufacturing & QC Analytical Support
Provide technical analytical review and approval of CMO manufacturing documents for routine commercial production
Perform technical assessment and approval of change controls impacting analytical methods, specifications, reference standards, and QC testing processes in close collaboration with Late Stage Analytical Development, Bioassay Development, and Drug Product Development Leads.
Serve as analytical subject matter expert (SME) for manufacturing deviations and QC laboratory investigations (OOS/OOT, atypical results), including root cause assessment and CAPA evaluation
Monitor ongoing method and process performance trends at the CMO to proactively 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 (BioPhorum or other consortia white papers).
Analytical Method Transfer – In-Country Testing & International Registration
Own and oversee analytical method transfer activities to support in-country/regional testing requirements as new marketing applications are submitted and approved internationally
Develop and execute method transfer risk assessments and protocols, acceptance criteria, and transfer reports in collaboration with receiving testing laboratories
Coordinate with Regulatory Affairs, CMC, and QA to align method transfer timelines with global submission and launch schedules
Ensure consistency methods/specifications across testing sites and support harmonization where appropriate
Global Health Authority Support
Provide analytical/CMC technical expertise in response to health authority questions from regulatory agencies as part of international expansion.
Draft and review technical responses to information requests related to analytical methods, specifications, validation, and control strategy
Cross-Functional Collaboration
Partner closely with the peer analytical leads responsible for method/process transfer and scale-up at the second-source CMO to ensure consistent analytical strategy across manufacturing sites and international QC labs.
Collaborate with CMC, Quality, Regulatory Affairs, Supply Chain, and CMO counterparts to support uninterrupted commercial supply
Represent Analytical Sciences on cross-functional teams for commercial lifecycle management activities
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, able to operate with a high degree of independence and exercise sound scientific judgment on complex, ambiguous problems with limited managerial oversight
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 and 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, with ability to author clear, defensible technical and regulatory documentation
Ability to travel domestically and internationally as needed
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
What Success Looks Like in This Role
Reliable, timely analytical technical review supporting uninterrupted commercial batch disposition
Successful, on-time method transfers enabling in-country testing for new international market launches
Clear, scientifically rigorous responses to global health authority questions that support timely application approvals
Strong, collaborative working relationship with the CMO and with the peer analytical leads overseeing analytical and process transfer/scale-up at second source manufacturing & QC site
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
Denali Therapeutics is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier using our proprietary TransportVehicle™ platform. We discover, develop and deliver medicines for people living with neurodegenerative, lysosomal storage and other serious diseases.
Offices: 161 Oyster Point Blvd, South San Francisco, California 94080, US · 5843 W Amelia Earhart Dr, Salt Lake City, Utah 84116, US
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