Principal Scientist, CMC Analytical Development - Commercial Products

## Principal Scientist, CMC Analytical Development - Commercial Products Apply locations:
South San Francisco time type:
Full time posted on:
Posted 5 Days Agojob requisition :
R-1616

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.

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 (Bio Phorum 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…