Senior Scientist, Purification Process Development at Denali Therapeutics in South San Francisco

Job description

• We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
• This position is responsible for characterizing/validating purification processes and authoring IND/BLA sections to support our large molecule pipeline.

Responsibilities

• Lead purification/downstream process characterization, tech transfer, and late-stage activities
• 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

Requirements

• PhD in Biology, Biochemistry, Chemical Engineering or related scientific discipline plus a minimum of 5+ years of purification development experience in the biotech/biopharma industry.
• Experience with purification process characterization and validation is required.
• Experience reviewing batch records and familiarity with Process Performance Qualification (PPQ) campaigns
• Familiarity with BLA authoring is preferred.
• 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
• Knowledge of process virology, including working with contract labs to plan and execute viral clearance studies, is desired
• 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

Skills

Preferred

• Familiarity with BLA authoring

Benefits

• Salary Range: $147,000.00 to $191,000.00 . 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.