What are the responsibilities and job description for the Director, Analytical and Formulation Development position at Denali Therapeutics Inc?
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. 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.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
Key Accountabilities/Core Job Responsibilities:
Independently lead late phase 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.
Oversee pivotal and BLA-enabling analytical development deliverables for late phase programs by serving as CMC analytical lead as well as providing technical oversight and mentorship to other CMC analytical leads.
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, critical quality attribute (CQA) assessments, and comparability exercises.
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 and process characterization/process validation (PC/PV) activities.
Provide technical guidance during investigations at CMOs/CROs in collaboration with Quality
Author and review technical development documents, relevant CMC sections of health authority submissions through BLA/MAA, and support agency interactions
Support technical execution and troubleshooting in the laboratory, as needed.
Drive the establishment of internal state-of-the-art analytical capabilities to support accelerated CMC development.
Responsible to 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
Qualifications/Skills:
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 and experience 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.
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.
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.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.
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 : $215,000 - $247,000
