Principal Scientist, Commercial and Late-Stage Purification Process Development

Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.

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 driving downstream 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 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 or MSAT 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.

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.