Senior CMC Analytical Scientist – Commercial Products

Denali Therapeutics; South San Francisco (CA); Vor Ort; USD 159.000 - 207.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

AnalyticalChemistry

Biologics analytical methods

Method transfer

Regulatory writing

Cross-functional collaboration

Communication skills

Ausbildung

PhD in Chemistry/Analytical Chemistry/Biochemistry

MS in Chemistry/related

Tools

HPLC/UPLC

Mass spectrometry

Glycan analysis

ELISA

Jobbeschreibung

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