Director, Analytical and Formulation Development
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company based in South San Francisco, California that is dedicated to defeating neurodegenerative diseases through rigorous therapeutic discovery and development. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies 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 Director 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).
- Independently lead analytical development, transfer, qualification, 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.
- Accountable for IND-enabling analytical development deliverables for multiple programs by serving as CMC analytical lead as well as providing technical oversight and mentorship to other CMC analytical leads.
- Hands-on, technical execution in the laboratory
- Develop and optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based analytical methods for product quality assessment.
- Assist in defining and executing overall biologics analytical development strategy to enable accelerated CMC development timelines.
- 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 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.
- PhD in Analytical Chemistry, Biochemistry, Chemical Engineering, Biophysics, or related scientific discipline plus a minimum of 6 – 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.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
Salary Range: $215,000.00 - $247,000.00. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
*This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
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