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

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

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.

Key Accountabilities/ Core Job 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/Skills:

• 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.

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

• Familiarity with BLA authoring and post-approval regulatory support 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.
 

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.