Principal Scientist, Late Stage Upstream 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.

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

We are seeking an experienced and driven scientist/engineer to lead late-stage upstream cell culture process development activities for clinical and commercial-stage large molecule programs. This individual will serve as the upstream lead for scale-up and tech transfer to manufacturing sites, establishing process validation (PV) strategy and PPQ/post-approval process support.

Key Accountabilities/ Core Job Responsibilities:

• Lead scale-up and tech transfer of the upstream process to manufacturing sites, ensuring alignment with control strategy and regulatory filings.

• Serve as the technical lead, responsible for upstream process activities for a late-stage large molecule programs including commercial manufacturing support

• Author and review relevant CMC documentation including PV protocols/reports and regulatory sections (e.g., BLA, IND amendments).

• Develop and execute strategies for process performance qualification (PPQ) and continued process verification (CPV).

• Collaborate cross-functionally with MSAT, Downstream, Analytical Development, CMC management, Manufacturing Operations, QA, QC, Regulatory, and Contract Manufacturers

• Represent upstream function in regulatory strategy, technical meetings, and CDMO interactions.

• Provide technical support for upstream process-related investigations, product impact assessments, change control assessments, CAPA assessments etc.

Qualifications/Skills:

• PhD in biology, biochemistry, chemical engineering or related scientific discipline with minimum 7 years of cell culture process development experience in the biotech/biopharma industry; or BS/MS with 12+ years of experience.

• In-depth understanding of CHO-based fed-batch processes, scale-up/scale-down principles, and statistical tools.

• Thorough understanding of cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and scaleup/tech transfer activities

• Demonstrated experience with late-stage upstream process development, PPQ strategy, tech transfer and BLA authoring

• Strong knowledge of regulatory expectations for process validation and control strategies.

• Excellent communication, leadership, and cross-functional collaboration skills.

• Demonstrated ability for taking initiative, creativity, and innovation in problem solving

• Experience working with novel large molecule formats such as bispecific antibodies and Fusion proteins/enzymes is a plus

• Demonstrated technical writing, critical thinking, scientific problem-solving and communication skills

Salary Range: $180,000.00 to $214,600.00 . 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

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.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.