Senior CMC Analytical Scientist – Commercial Products

Denali Therapeutics Inc.

South San Francisco (CA)

On-site

USD 159,000 - 207,000

Full time

14 days+

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Job summary

Denali Therapeutics Inc. is seeking a Principal Scientist for CMC Analytical Development focused on commercial products. You will lead analytical strategy for biologics, oversee method transfers, and support global submissions and health authority interactions.

The role requires deep expertise in analytics, regulatory practices, and cross-functional leadership. The position supports commercial manufacturing and QC activities, guiding deviations investigations and ensuring compliance with ICH and

Qualifications

PhD/MS in chemistry or related field with industry experience.
Strong hands-on experience with biologics analytical methods.
Experience with analytical method transfer and validation (ICH Q2).
Familiarity with regulatory submissions and health authority interactions (FDA/EMA).
Proven ability to work independently and lead cross-functional teams.

Responsibilities

Provide analytical SME expertise for commercial manufacturing and QC activities.
Lead analytical method transfers to support in-country testing and international registrations.
Oversee deviations investigations, CAPA, and OOS/OOT investigations.
Collaborate with Regulatory Affairs, CMC, QA, and Supply Chain to align timelines.
Represent Analytical Sciences on cross-functional teams for lifecycle management.