Principal Downstream Bioprocess Scientist – Commercial

Denali Therapeutics Inc; South San Francisco (CA); Sur place; USD 159 000 - 207 000; Plein temps

Avantages offerts par ce poste

401k

Healthcare coverage

ESPP

Broad range of benefits

Résumé du poste

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).

Responsabilités

• 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.

Connaissances

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

Formation

PhD in Biology/Biochemistry/Chemical Engineering

Outils

AKTA protein purification systems

Description du poste

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.