Principal Scientist, Purification Process Development

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.
• Coverage internal team to generate late-stage process characterization and/or validation data packages.
• Select/coordinate 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.
• 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.

Pay & 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 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers.