Principal Scientist, Analytical And Formulation Development

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.
The Opportunity
We are seeking a talented and motivated Principal Scientist with a strong background in characterizing protein therapeutics using mass spectrometry-based tools to provide technical oversight and execution of protein characterization activities in our large molecule CMC analytical development group.
Key Responsibilities

• Lead internal large molecule CMC-focused mass spectrometry and extended characterization activities including primary sequence determination, PTM analysis, and higher order structure characterization for large molecule CMC portfolio.
• Develop phase-appropriate product extended characterization strategies for large molecule CMC portfolio including elucidation of structure for early vs. late phase programs as well as characterization strategy for product variants and forced degraded samples.
• Hands-on, technical execution of LC-MS based characterization activities to support comparability evaluations, inform CQA assessments, determine structure-function-activity relationships, and further product understanding.
• Author and review technical development documents and relevant sections of health authority filings.
• Maintain timely and accurate lab records consistent with good documentation practices.
• Ensure rapid and timely analytical support for cell-line, bioprocess, and Formulation Development activities.
• Support late phase analytical development and product characterization activities for one or more large molecule programs in CMC development.
• Contribute to the development & implementation of overall analytical control strategy to enable commercialization of complex biotherapeutics.
• Oversee product characterization strategy and execution including elucidation of structure as well as characterization of forced degraded panel and minor variants.
• Perform critical quality attributes (CQAs) assessments to support phase-appropriate control system strategy.
• Provide oversight of analytical method transfer, qualification, and validation activities at external/internal QC laboratories.

Requirements:

• PhD in Analytical Chemistry, Chemical Engineering, Biophysics or related scientific discipline plus 8+ years direct CMC-focused analytical development experience for protein therapeutics in the biotech/biopharma industry; or BS/MS with 12+ years of relevant experience.
• In depth knowledge and extensive hands-on experience developing and applying mass spectrometry-based methods (Intact/reduced MS, subunit analysis, 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 in the context of protein therapeutics.
• Well versed in characterizing protein therapeutic product variants and forced degradation samples.
• Previous experience authoring relevant IND/BLA sections (e.g. Analytical comparability, Elucidation of Structure, Justification of Specifications, etc.)
• Previous experience in developing a wide array of analytical protein characterization and biophysical methods (e.g. HPLC-based methods, cIEF, capillary electrophoresis, LC/MS - based multi-attribute methods (MAM), peptide mapping, spectrophotometry, light scattering, etc.)
• Demonstrated track record of successfully transferring and qualifying analytical methods for protein therapeutic development programs, developing control strategies, and successful health authority submissions
• Strong grasp of statistical approaches for design-of-experiments (DoE) analytical method development, robustness testing, and data analysis.
• Excellent communication, collaboration, organizational, and scientific problem-solving skills.

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: $158,000.00 to $206,780.00. 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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