Downstream Process Leader for Commercial Biologics

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

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Denali Therapeutics in South San Francisco, CA, seeks an experienced Senior Downstream Process Scientist to drive downstream purification activities for commercial and near-commercial biologics. You will lead technical efforts across process verification, investigations, deviations, and cross-site alignment, shaping lifecycle management for late-stage programs.

The ideal candidate has a PhD and 10+ years in bioprocessing, with hands-on AKTA purification, process characterization, and regulatory

Qualifications

• PhD with 10+ years in bioprocessing and downstream purification.
• Experience with commercial process support and tech transfers.
• Ability to review batch records, support deviations, and assess process performance.
• Experience with regulatory interactions and CDMO collaborations.
• DOE, process characterization, and analytics in bioprocessing.
• Strong problem-solving, communication and cross-functional collaboration.

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.

Skills

Downstream purification

Process characterization

Design of experiments

Cross-functional collaboration

Regulatory filing support

Critical thinking

Root-cause investigations

Communication skills

Education

PhD in Biology/ Biochemistry/ Chemical Engineering

Tools

AKTA purification systems

Biophysical characterization methods

Job description

Denali Therapeutics in South San Francisco, CA, seeks an experienced Senior Downstream Process Scientist to drive downstream purification activities for commercial and near-commercial biologics. You will lead technical efforts across process verification, investigations, deviations, and cross-site alignment, shaping lifecycle management for late-stage programs.

The ideal candidate has a PhD and 10+ years in bioprocessing, with hands-on AKTA purification, process characterization, and regulatory