Denali recently achieved a major company milestone with the commercial launch of its first product, AVLAYAH, approved through the FDA's accelerated approval pathway. As the product transitions into routine commercial production and Denali pursues marketing applications in additional countries, we are seeking a Principal Scientist to join our Large Molecule Analytical Development Team to serve as a Commercial Analytical Lifecycle Lead. This individual will provide technical analytical expertise for commercial manufacturing and QC activities; lead analytical method transfers to support in-country testing; and lead international registration of the established commercial process with additional global health authorities. The Commercial Analytical Lifecycle Lead is expected to partner closely with peer Late Stage Analytical Development and Bioassay Development Leads responsible for driving successful analytical transfer & registration of a second-source manufacturing and QC site. The scope of the role is expected to expand as additional programs advance to commercialization.

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

Minimum 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, 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

Preferred 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

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

Salary Range: $159,000.00 to $207,000.00 .  Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

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.