Senior Scientist, Late-Phase Analytics & Formulation

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

Benefits offered by this job

401k

Healthcare

ESPP

Other benefits

Job summary

Denali Therapeutics Inc. is seeking a Principal Scientist to provide strategic leadership in late-phase and commercial analytical development and extended characterization.

You will oversee control strategy development at CDMOs and deliver across CQAs, bridging, and validation activities while mentoring junior staff. You will develop and optimize MS- and chromatographic-based methods, perform in-depth physicochemical characterization, and drive regulatory-ready documentation for health authority

Qualifications

• PhD or equivalent with 10+ years in analytical development for protein therapeutics.
• Experience leading multidisciplinary analytical and quality teams to meet milestones.
• Experience with large molecule late phase and commercial analytical lifecycles.
• Hands-on development of analytical protein characterization and biophysical methods (HPLC, cIEF, CE, LC/MS, peptide mapping, spectrophotometry, SPR, light scattering).
• MS-based method development experience (intact/reduced MS, peptide mapping, glycosylation profiling).
• Experience with bioanalytical assays or MS characterization approaches is a plus.
• Strong DoE and data analysis skills; knowledge of GMP and regulatory guidance.
• Ability to collaborate across teams and with CDMOs to drive program timelines.
• Excellent written and oral communication; detail-oriented and problem-solving mindset.

Responsibilities

• Independently lead analytical development and product characterization for CMC late phase/commercial molecules, including CDMO management.
• Oversee method qualification/validation and transfer at CDMOs; support bridging and comparability studies.
• Define and execute overall biologics analytical development strategy for accelerated timelines.
• Provide hands-on lab work and mentorship to junior staff.
• Develop and optimize chromatography-, capillary-, spectroscopy-, and MS-based methods for product quality.
• Perform in-depth physical/chemical characterization of complex biologics.
• Lead CQAs assessments to support control strategies; support QA investigations with CMOs/CROs.
• Author/review development documents and sections of health authority filings.
• Establish state-of-the-art analytical capabilities to accelerate CMC development.
• Ensure rapid, cross-functional analytical support and timely deliverables.
• Maintain proficiency with latest analytical technologies and guidelines.
• Maintain accurate lab records per good documentation practices.
• Lead direct reports with goals, growth plans, and training compliance.

Skills

Analytical Development

CDMO Management

Mass Spectrometry

Biologic Characterization

DoE

GMP Knowledge

Cross-functional Leadership

Team Mentoring

Scientific Writing

Communication

Education

PhD in Analytical Chemistry

BS/MS with 14+ years experience

Tools

HPLC-based methods

cIEF

Capillary electrophoresis

LC/MS

Peptide mapping

Spectrophotometry

SPR

Light scattering

Job description

Denali Therapeutics Inc. is seeking a Principal Scientist to provide strategic leadership in late-phase and commercial analytical development and extended characterization.

You will oversee control strategy development at CDMOs and deliver across CQAs, bridging, and validation activities while mentoring junior staff. You will develop and optimize MS- and chromatographic-based methods, perform in-depth physicochemical characterization, and drive regulatory-ready documentation for health authority