Commercial Analytical Lifecycle Lead, CMC

Denali Therapeutics Inc; South San Francisco (CA); On-site; USD 159,000 - 207,000; Full time

Benefits offered by this job

401(k) match

Healthcare coverage

Employee stock purchase plan

Job summary

Denali Therapeutics Inc. is seeking a Principal Scientist for the Large Molecule Analytical Development team to lead commercial analytical lifecycle activities.

The role focuses on providing technical analytical expertise for in-country testing, method transfers, and international registrations of established processes. You will partner with Late Stage Analytical Development, Bioassay Development, and Drug Product Development leads to enable transfers and registrations across global sites.

Qualifications

• Demonstrated track record as a recognized analytical/technical SME with independence and sound judgment.
• Strong written and verbal communication skills for regulatory documentation.
• Experience with biologics manufacturing and QC support, post-approval activities.

Responsibilities

• Provide technical analytical review of CMO manufacturing documents for routine commercial production.
• Lead analytical method transfers and registration activities for international submissions.
• Manage deviations, investigations, CAPA, and OOS/OOT analyses with root-cause assessment.
• Ensure compliance with current guidelines (ICH, Pharmacopeia, FDA/EMA) and best practices.
• Coordinate with Regulatory Affairs, CMC and QA to align transfer timelines with launches.
• Collaborate across cross-functional teams for consistent analytical strategy across sites.

Skills

Analytical science expertise

Independent problem solving

Excellent communication

Education

BS/MS/PhD in Chemistry or related field

Tools

Biologics analytical methods (ELISA, HPLC/UPLC, MS)

ICH Q2 method validation

Job description

Denali Therapeutics Inc. is seeking a Principal Scientist for the Large Molecule Analytical Development team to lead commercial analytical lifecycle activities.

The role focuses on providing technical analytical expertise for in-country testing, method transfers, and international registrations of established processes. You will partner with Late Stage Analytical Development, Bioassay Development, and Drug Product Development leads to enable transfers and registrations across global sites.