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About the Role
Denali Therapeutics is seeking a Principal Scientist to join the Large Molecule Analytical Development Team as a Commercial Analytical Lifecycle Lead. This role will provide technical analytical expertise for commercial manufacturing and QC activities, lead analytical method transfers for in-country testing, and oversee the international registration of the established commercial process with global health authorities. The position is crucial for supporting the commercial launch and expansion of Denali's first product, AVLAYAH, and will involve close collaboration with peer leads and cross-functional teams.
Responsibilities
- 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.
- Serve as analytical subject matter expert (SME) for manufacturing deviations and QC laboratory investigations, 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 and best practices.
- Own and oversee analytical method transfer activities to support in-country/regional testing requirements.
- Develop and execute method transfer risk assessments and protocols, acceptance criteria, and transfer reports.
- Coordinate with Regulatory Affairs, CMC, and QA to align method transfer timelines with global submission and launch schedules.
- Ensure consistency of methods/specifications across testing sites and support harmonization.
- Provide analytical/CMC technical expertise in response to health authority questions from regulatory agencies.
- Draft and review technical responses to information requests related to analytical methods, specifications, validation, and control strategy.
- Represent Analytical Sciences on cross-functional teams for commercial lifecycle management activities.
Requirements
- 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 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.
- 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.
- 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.
Skills
- Potency/enzymatic activity assays
- ELISA
- HPLC/UPLC
- Capillary electrophoresis
- Mass spectrometry
- Glycan analysis
- Method transfer
- Method validation/qualification
- ICH Q2
- Technical transfer documentation
- Global regulatory requirements
- CMO oversight
- Contract testing laboratory oversight
- Written communication
- Verbal communication
- Technical documentation
- Regulatory documentation
Location
- Remote
- Hybrid
- Onsite
Work Type
- Full-time
Experience Level
- Principal Scientist
- 10+ years (PhD)
- 14+ years (MS/BS)
Education Level
- BS
- MS
- PhD
Salary/Compensations
- $159,000.00 to $207,000.00
Benefits
- 401k
- Healthcare coverage
- ESPP
About the Company
- Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through its 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.
- Denali recently achieved a major company milestone with the commercial launch of its first product, AVLAYAH, approved through the FDA's accelerated approval pathway.
Equal Opportunity
- 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.