Director, Analytical and Formulation Development

Denali Therapeutics-posted about 1 year ago
$215,000 - $247,000/Yr
Full-time • Senior
South San Francisco, CA
Professional, Scientific, and Technical Services
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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.

  • 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.
  • 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.
  • Experience with developing bioanalytical assays or advanced mass spectrometry characterization approaches.
  • Familiarity with applicable GMP requirements.
  • Employee stock purchase plan
  • Health insurance
  • 401(k)
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