Associate Director, Analytical and Formulation Development

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology, principles of translational medicine, and excellence in technical development.

The Opportunity

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 to analytical development and extended characterization activities as well as oversight of control strategy development and implementation at contract development and manufacturing organizations (CDMOs).

Key Responsibilities

• Independently lead analytical development and product characterization activities for one or more molecules in CMC development including managing CDMO interactions and driving the development and implementation of overall analytical control strategy.
• Provide oversight of analytical method transfer, qualification, and validation activities at CDMOs.
• Assist in defining and executing overall biologics analytical development strategy to enable accelerated CMC development 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 to build understanding of critical quality attributes (CQAs) and support global health authority filings.
• 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 analytical support for cell-line, bioprocess, and formulation development activities.
• Maintain proficiency in the latest analytical technologies as well as emerging analytical development strategies
• Maintain timely and accurate lab records consistent with good documentation practices.

Requirements

• PhD in Analytical Chemistry, Biochemistry, Chemical Engineering, Biophysics, or related scientific discipline plus a minimum of 8+ years analytical development experience for protein therapeutics in the biotech/biopharma industry; or BS/MS with a minimum of 12+ years of experience.
• Previous experience successfully managing multidisciplinary analytical and quality teams to meet program milestones and timelines.
• Demonstrated track record of successfully transferring and qualifying analytical methods at CMOs for protein therapeutic development programs including familiarity with applicable GMP requirements
• In-depth knowledge and extensive hands-on experience in developing a wide array of analytical protein characterization and biophysical methods (e.g. HPLC-based methods, cIEF, capillary electrophoresis, LC/MS, peptide mapping, spectrophotometry, SPR, light scattering, etc.)
• Strong background in developing mass spectrometry-based methods (Intact/reduced MS, peptide mapping, N-/O-glycosylation profiling, disulfide linkage determination, LC-MS/MS analysis) for protein sequence confirmation, identification and characterization of product variants, and comparability evaluations considered highly preferable.
• Prior experience with developing bioanalytical assays or advanced mass spectrometry characterization approaches (tandem mass spectrometry, quantitative analysis, hydrogen-deuterium exchange, etc.) considered a plus.
• Strong grasp of statistical approaches for design-of-experiments (DoE) analytical method development, robustness testing, and data analysis.
• Demonstrated ability to work effectively and collaboratively with other scientists on cross-functional projects teams as well as CDMOs.
• Ability to make thoughtful and meaningful recommendations and/or manage relationships in order to drive efficient advancement of the portfolio.
• Ability to balance competing priorities and thrive in a dynamic, fast-paced environment.
• Excellent critical thinking, scientific problem-solving, and organizational skills
• Excellent oral and written communication skills
• Motivated, detail-oriented, scientifically driven individual with a creative approach to problem solving.