Principal Scientist, Commercial & Late-Stage Cell Culture Process Development

About the role

This position is responsible for driving upstream technical activities for commercial and late-stage process development for Denali’s commercial and near-commercial biologics portfolio.

Responsibilities

• Serve as upstream cell culture 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 ensuring 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

• Typically requires a PhD in Biology, Biochemistry, Chemical Engineering or related scientific discipline, plus 10+ years of related work experience.
• Strong experience with commercial process support and technology transfers, upstream cell culture characterization, and process validation.
• Experience managing post-approval changes as a technical SME in collaboration with manufacturing 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 upstream cell culture processes to support early or late-stage clinical production.
• In-depth understanding of CHO-based fed-batch processes, scale-up/scale-down principles and statistical tools.
• Familiarity with BLA authoring and post-approval regulatory support is preferred.

Skills

• Excellent critical thinking, scientific problem-solving and communication skills.

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.

Benefits

• Competitive total rewards package, including a 401k, healthcare coverage, Employee Stock Purchase Plan (ESPP), and a broad range of other benefits.

Learn more at https://www.denalitherapeutics.com/careers.