Director, Analytical and Formulation Development

Denali Therapeutics • South San Francisco, CA

371d • $215,000 - $247,000

About The Position

The Director of Analytical and Formulation Development at Denali Therapeutics is responsible for providing strategic technical leadership in late-phase analytical development and characterization activities for large molecules. This role involves oversight of control strategy development and implementation at manufacturing and QC testing sites, ensuring the delivery of high-quality therapeutics for neurodegenerative diseases. The position requires collaboration with cross-functional teams and external partners to drive analytical development and support regulatory submissions.

Requirements

• PhD in Analytical Chemistry, Biochemistry, Chemical Engineering, Biophysics, or related scientific discipline plus a minimum of 8-10 years analytical development experience for protein therapeutics in the biotech/biopharma industry; or BS/MS with a minimum of 15+ years of experience.
• Previous experience serving as CMC analytical lead through BLA/MAA submission for large molecule programs.
• Demonstrated track record of successfully transferring and qualifying analytical methods at CMOs for protein therapeutic development programs.
• In-depth knowledge and extensive hands-on experience in developing a wide array of analytical protein characterization and biophysical methods.
• Strong background in developing mass spectrometry-based methods for protein sequence confirmation and characterization of product variants.
• Prior experience with developing bioanalytical assays or advanced mass spectrometry characterization approaches considered a plus.
• Strong grasp of statistical approaches for design-of-experiments (DoE) analytical method development and data analysis.
• Ability to work effectively and collaboratively with other scientists on cross-functional projects teams.

Nice To Haves

• Experience with developing bioanalytical assays or advanced mass spectrometry characterization approaches.
• Familiarity with applicable GMP requirements.

Responsibilities

• Independently lead late phase analytical development, transfer, qualification, and product characterization activities for one or more molecules in CMC development.
• Oversee pivotal and BLA-enabling analytical development deliverables for late phase programs as CMC analytical lead.
• Develop and optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based analytical methods for product quality assessment.
• Perform in-depth physical/chemical characterization of complex biologics supporting elucidation of structure and critical quality attribute assessments.
• Define and execute overall late phase biologics analytical development strategy to enable accelerated CMC development timelines.
• Ensure rapid and timely analytical support for cell-line, bioprocess, and formulation development activities.
• Provide technical guidance during investigations at CMOs/CROs and review technical development documents.
• Support agency interactions and health authority submissions through BLA/MAA.
• Drive the establishment of internal state-of-the-art analytical capabilities to support accelerated CMC development.
• Lead direct reports through annual goal setting, growth planning, and provide ongoing feedback.

Benefits

• Employee stock purchase plan
• Health insurance
• 401(k)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree