Principal Downstream Bioprocess Scientist – Commercial
Denali Therapeutics Inc
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Benefits offered by this job
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
Education
Tools
Job description
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.
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