This position is responsible for leading, characterizing and validating purification processes, as well as authoring IND/BLA sections to support our large molecule pipeline. Key Accountabilities/ Core Job 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/Skills: - 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. 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 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.