Principal Scientist, Purification Process 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. Position Overview This position is responsible for leading, characterizing and validating purification processes, as well as authoring IND/BLA sections to support our large molecule pipeline. Responsibilities Independently lead purification/downstream process characterization, tech transfer, and late‑stage activities, anticipating issues and driving execution. Author protocols, coordinate study execution, review analytical results, generate/review reports, and author IND/BLA sections. Coordinate internal team to generate late‑stage process characterization and/or validation data packages. Support selection/coordination of CDMOs as needed to generate high‑quality late‑stage data packages. Transfer purification processes to CMOs and support ongoing manufacturing activities as needed. Support other late‑stage projects and apply lessons learned to current projects. Design and execute lab‑scale chromatography and filtration studies to inform and support large‑scale process decisions. Maintain existing workflows to provide purification support for cell line and cell culture development activities. Execute methods for in‑process testing using ELISA, HPLC, UV and SDS‑Page based analytics. Qualifications Typically requires a PhD in Biology, Biochemistry, Chemical Engineering or related scientific discipline, plus 10+ years’ of related work experience. Experience with purification process characterization and validation. Experience reviewing batch records and familiarity with Process Performance Qualification (PPQ) campaigns. Proven track record of representing bioprocess functions in cross‑functional teams and working effectively with CMOs. Broad experience in process characterization, design of experiments and analytics. Experience developing protein purification processes to support early or late‑stage clinical production. Expertise in AKTA protein purification systems and antibody characterization methods including HPLC, LC/MS, SDS‑PAGE, DLS and other biophysical techniques. Excellent critical thinking, scientific problem‑solving and communication skills. Familiarity with BLA authoring is preferred. Knowledge of process virology, including working with contract labs to plan and execute viral clearance studies is preferred. Compensation and Benefits Salary Range: $159,000.00 to $207,000.00. 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 401(k), healthcare coverage, ESPP and a broad range of other benefits. Equal Opportunity Employer Denali is proud to be an equal opportunity employer and does 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. #J-18808-Ljbffr Denali Therapeutics Inc