Principal Scientist, Commercial and Late-Stage Purification Process Development

Denali Therapeutics Inc; South San Francisco (CA); On-site; USD 159,000 - 207,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Broad range of benefits

Job summary

Denali Therapeutics Inc in South San Francisco seeks a senior downstream purification lead to support commercial manufacturing and lifecycle management. You will drive process verification, investigations, deviation support, and cross-site alignment to ensure robust manufacturing and continuous improvement.

The ideal candidate holds a PhD and 10+ years in bioprocess development, with AKTA systems, analytics, and regulatory support expertise.

Qualifications

• PhD in biology, biochemistry, chemical engineering, or related field.
• 10+ years of bioprocess development and manufacturing support.
• Experience with commercial process support and tech transfers.
• Experience reviewing batch records and deviation investigations.
• Cross-functional collaboration with CDMOs and internal teams.
• Expertise in downstream purification and purification process characterization.
• AKTA purification systems and antibody characterization knowledge.
• Strong problem-solving and communication skills.
• Familiarity with BLA authoring and post-approval regulatory support (preferred).

Responsibilities

• Lead downstream purification technical activities for commercial manufacturing.
• Support lifecycle management and tech transfer validation.
• Ensure cross-site alignment and process understanding.
• Design and oversee small-scale studies to inform large-scale decisions.
• Develop risk assessments and process history files.
• Support late-stage process development and standardize lifecycle practices.

Skills

Downstream purification

Process transfers

Batch record review

Deviation investigations

Cross-functional teams

DOE design of experiments

AKTA purification systems

Antibody characterization

Biophysical techniques

Critical thinking

Communication

BLA regulatory support

Education

PhD in Biology/Biochemistry/Chemical Engineering

Tools

AKTA protein purification systems

Job description

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.

Salary Range:

$159,000.00 to $207,000.00

Benefits:

• 401k, healthcare coverage, ESPP and a broad range of other benefits.

Company Culture and Values

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. 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.

Commitment to Diversity and Inclusion

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.

Life at Denali

“Life at Denali” is a living reflection of our values: trust, unity, grit and growth. These are not just words we share—they shape how we show up, collaborate and push boundaries together. From the lab to the community, across functions and milestones, our culture thrives on shared purpose and relentless pursuit.

Learn More

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

General Compensation Statement

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. 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.