Denali Therapeutics

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.

This position will support Technical Operations through leading state of the art analytical method development, method troubleshooting, method transfer/validation, and authoring of relevant CMC sections in support of regulatory filings/responses. A primary focus of the role will be to provide technical expertise to both internal and external development and QC labs in support of GMP method implementation and lifecycle management.

Key Accountabilities/Core Job Responsibilities:

• Responsible for the management/leadership of early/late stage and commercial method transfers, qualifications and validations at internal and external laboratories.
• Author/Review transfer/validation plans, protocols and reports
• Author and review technical development documents and relevant sections of health authority filings.
• Serves as a technical liaison between the Analytical and Formulation Development Group and the Quality Control / Manufacturing Sciences Groups. Supports Quality and manufacturing investigations as appropriate.
• Develop and optimize phase-appropriate methods to support testing and characterization of our large molecule CMC portfolio.
• 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.
• Maintain timely and accurate lab records consistent with good documentation practices.

Qualifications/Skills:

• PhD in Biochemistry or related scientific field with 5+ years experience in the biopharmaceutical industry. MS or BS in Biochemistry or related scientific field with 8+ years experience in the biopharmaceutical industry.
• Demonstrated scientific knowledge in relevant analytical methodologies (mass spectrometry, chromatography, capillary electrophoresis, bioassays, etc) used for release/stability testing and characterization of large molecules
• Demonstrated broad knowledge and experience in analytical method development, method transfers between QC testing labs, and GMP qualification, validation and troubleshooting
• Established knowledge of applicable global drug development and regulatory standards and current expectations
• Established knowledge and application of cGMPs/GLPs, USP, ICH, FDA CMC Guidance Documents
• Experience with authoring clinical and/or commercial CMC technical sections of regulatory submissions and addressing regulatory authorities on technical matters
• Strong analytical and strategic thinking
• Demonstrated problem solving capabilities and cross functional understanding
• Excellent communication skills (oral, written, presentation)
• Highly preferred: Experience working with CMO/CDMOs
• Highly preferred: Experience with establishing reference standard qualification and stability testing plans

Salary Range: $138,000.00 to $174,000.00 . 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.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.