Senior Scientist (GMP/QC Validation)

About the position

At Denali, we are dedicated to developing breakthrough therapies for neurodegenerative diseases. 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.

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.

Requirements

• 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).

Nice-to-haves

• Experience working with CMO/CDMOs.
• Experience with establishing reference standard qualification and stability testing plans.

Benefits

• 401k
• healthcare coverage
• ESPP
• broad range of other benefits