Principal Scientist, Late Phase and Commercial Analytical and Formulation Development

Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary Transport Vehicle™ platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. As Denali builds internal capabilities to support rapid process and formulation development for our diverse pipeline of large molecules, we are seeking a talented and motivated Principal Scientist to provide strategic technical leadership for late phase and commercial analytical development and extended characterization activities as well as oversight of control strategy development and implementation at contract development and manufacturing organizations (CDMOs).

• Independently lead analytical development and product characterization activities for one or more molecules in the CMC late phase/commercial space, including managing CDMO interactions and driving the development and implementation of overall analytical control strategy.
• Provide oversight of analytical method qualification, validation, and transfer activities at CDMOs, as well as method bridging, comparability, and extended characterization studies.
• Define execute overall biologics analytical development strategy to enable accelerated CMC development and commercial timelines.
• Hands‑on, technical execution in the laboratory while providing mentorship to junior colleagues.
• 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.
• Lead critical quality attributes (CQAs) assessments to support phase‑appropriate control system strategy.
• Provide technical guidance during testing‑related investigations at CMOs/CROs in collaboration with Quality.
• Author and review technical development documents and relevant sections of health authority filings.
• Drive the establishment of internal state‑of‑the‑art analytical capabilities to support accelerated CMC development.
• Ensure rapid and timely, cross‑functional analytical support. all relevant CMC‑related deliverables.
• Maintain proficiency in the latest analytical technologies and industry guidelines, as well as emerging analytical development strategies.
• Maintain timely and accurate lab records consistent with good documentation practices.
• Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.

• PhD in Analytical Chemistry, Biochemistry, Chemical Engineering, Biophysics, or a related scientific discipline, plus a minimum of 10 years of analytical development experience for protein therapeutics in the biotech/biopharma industry; or BS/MS with a minimum of 14 years of relevant experience.
• Previous experience successfully managing multidisciplinary analytical and quality teams to meet program milestones and timelines.
• Previous experience with large molecule late phase and commercial analytical lifecycle activities, including leading/executing successful method transfers, method qualification and validation, bridging studies,…