Principal Scientist – Late-Phase Analytics & Formulation

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

Benefits offered by this job

401k

Healthcare coverage

Employee stock purchase plan (ESPP)

Job summary

Denali Therapeutics is seeking a Principal Scientist to provide strategic leadership for late-phase and commercial analytical development and extended characterization. You will oversee control strategy development and implementation at CDMOs, lead method qualification/validation, and guide cross-functional teams to accelerate CMC timelines.

You will mentor scientists, develop state-of-the-art analytical capabilities, and ensure compliant documentation while maintaining strong QA collaboration

Qualifications

• PhD in Analytical Chemistry, Biochemistry, Chemical Engineering, Biophysics, or related field with 10+ years in protein analytics.
• Experience leading multidisciplinary analytical and quality teams.
• Experience with late-phase and commercial analytical lifecycle for large molecules.

Responsibilities

• Lead analytical development and product characterization for late-phase/commercial molecules.
• Oversee CDMO interactions and method transfers/validation.
• Define and execute biologics analytical development strategy for accelerated CMC timelines.
• Mentor junior colleagues and author development documents.

Skills

Analytical leadership

Cross-functional work

DoE statistics

Mass spectrometry

HPLC methods

Biopharma experience

Communication

Problem solving

Education

PhD in Analytical Chemistry or related field

BS/MS with 14+ years experience

Tools

LC-MS/MS

cIEF

Capillary electrophoresis

SPR

Job description

Denali Therapeutics is seeking a Principal Scientist to provide strategic leadership for late-phase and commercial analytical development and extended characterization. You will oversee control strategy development and implementation at CDMOs, lead method qualification/validation, and guide cross-functional teams to accelerate CMC timelines.

You will mentor scientists, develop state-of-the-art analytical capabilities, and ensure compliant documentation while maintaining strong QA collaboration