Principal Scientist, Commercial and Late-Stage Purification Process Development

Key Accountabilities/Core Job Responsibilities

• Serve as downstream purification technical lead for commercial manufacturing including continued process verification, investigations, deviation support, and cross-site alignment.
• Support lifecycle management activities for commercial products, including process improvements, tech transfer validation activities, local and cross-site change management, regulatory filing updates (CBE, PAS, Ex-US expansion), and responses to health authority questions.
• Drive technical continuity and alignment across CDMO and internal manufacturing sites by ensuring process understanding, lessons learned and technical decisions are consistently captured and applied.
• Design, oversee, and interpret small-scale process development studies that inform large-scale manufacturing decisions, support root-cause investigations, and enable lifecycle improvements.
• Build and maintain technical risk assessments (e.g., FMEA) and process history files to support robust commercial manufacturing and future late-stage programs.
• Support the incoming late-stage process development pipeline and commercial programs by applying best practices, platform knowledge, and prior manufacturing experience while contributing to standardization of lifecycle management practices.

Qualifications/Skills

• Typically requires a PhD in Biology, Biochemistry, Chemical Engineering, or a related scientific discipline, plus 10+ years of related work experience.
• Strong experience with commercial process support and technology transfers, downstream purification process characterization, and process validation.
• Experience managing post-approval changes as a technical SME in collaboration with site, regulatory, supply chain and quality.
• Experience reviewing batch records, supporting deviation investigations, and assessing process performance during manufacturing campaigns.
• Proven track record of representing bioprocess functions in cross-functional teams and working effectively with CDMOs.
• Broad experience in process characterization, design of experiments, and analytics.
• Experience developing downstream purification processes to support early- or late-stage clinical production.
• Expertise in AKTA protein purification systems, antibody characterization methods, and other biophysical techniques.
• Excellent critical thinking, scientific problem-solving, and communication skills.
• Familiarity with BLA authoring and post-approval regulatory support is preferred.

Pay

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.