Principal Scientist, Process Development
Gilead Sciences
15 days ago
On-site
San Francisco Bay Area
Operations
Principal Scientist, Purification Process Development (Pre-Pivotal) – Foster City, CA
Key Responsibilities:
- Establish and maintain a purification lab for rapid manufacturability assessment, purification process development, and scaleup.
- Represent the department in CMC development teams; may lead molecule manufacturability assessment teams.
- Lead purification process development; independently design lab-scale experiments and ensure data integrity/compliance (hands-on execution expected).
- Lead process transfer to internal and contract manufacturing facilities to produce GMP and non-GMP drug substances on time with high success rate; provide person-in-plant technical oversight and lead atypical event investigations.
- Review GMP/non-GMP technical documentation (batch records, SOPs, guidance documents, reports).
- Author/review/coach CMC regulatory sections of IND/INDa; contribute to regulatory strategies and support agency interactions/inspections.
- Hire and develop scientists; mentor on purification process development, experimental design/execution, and process transfer.
- Drive purification platform development and technology evaluation/implementation to enable fast first-in-human timelines; improve workflows for screening developable lead molecules.
- Collaborate with Analytical, Cell Culture, Formulation, Research, Clinical Operations, and Program Strategy.
- Contribute to strategies and long-range plans aligned with company priorities; participate in cross-functional initiatives.
- Adhere to budget and all training, compliance, and safety requirements.
Qualifications:
- Ph.D. (5+ years) or M.S. (9+ years) or B.S. (11+ years) in chemical/bio/bioengineering or related field with biologics purification development experience and people-leader accountabilities.
- Demonstrated experience in process transfer to clinical manufacturing and technical leadership in process troubleshooting.
- Knowledge of single-use manufacturing tech and GMP guidelines (plus).
- Knowledge of FDA/EMA/ICH guidelines; experience authoring CMC sections in INDs.
- Working knowledge of lab automation, data science, and knowledge management (plus).
Preferred:
- Collaboration; building/developing high-performing teams; accountability and cross-functional influence; ability to set measurable goals and prioritize resources.
- Inclusion, talent development, and empowerment leadership.
Application instruction:
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.
Key Responsibilities:
- Establish and maintain a purification lab for rapid manufacturability assessment, purification process development, and scaleup.
- Represent the department in CMC development teams; may lead molecule manufacturability assessment teams.
- Lead purification process development; independently design lab-scale experiments and ensure data integrity/compliance (hands-on execution expected).
- Lead process transfer to internal and contract manufacturing facilities to produce GMP and non-GMP drug substances on time with high success rate; provide person-in-plant technical oversight and lead atypical event investigations.
- Review GMP/non-GMP technical documentation (batch records, SOPs, guidance documents, reports).
- Author/review/coach CMC regulatory sections of IND/INDa; contribute to regulatory strategies and support agency interactions/inspections.
- Hire and develop scientists; mentor on purification process development, experimental design/execution, and process transfer.
- Drive purification platform development and technology evaluation/implementation to enable fast first-in-human timelines; improve workflows for screening developable lead molecules.
- Collaborate with Analytical, Cell Culture, Formulation, Research, Clinical Operations, and Program Strategy.
- Contribute to strategies and long-range plans aligned with company priorities; participate in cross-functional initiatives.
- Adhere to budget and all training, compliance, and safety requirements.
Qualifications:
- Ph.D. (5+ years) or M.S. (9+ years) or B.S. (11+ years) in chemical/bio/bioengineering or related field with biologics purification development experience and people-leader accountabilities.
- Demonstrated experience in process transfer to clinical manufacturing and technical leadership in process troubleshooting.
- Knowledge of single-use manufacturing tech and GMP guidelines (plus).
- Knowledge of FDA/EMA/ICH guidelines; experience authoring CMC sections in INDs.
- Working knowledge of lab automation, data science, and knowledge management (plus).
Preferred:
- Collaboration; building/developing high-performing teams; accountability and cross-functional influence; ability to set measurable goals and prioritize resources.
- Inclusion, talent development, and empowerment leadership.
Application instruction:
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.