Scientist, Process Development
Gilead Sciences
16 days ago
On-site
San Francisco Bay Area
Operations
Scientist, Purification Process Development - Pre-Pivotal Biologics (Foster City, CA)
Key Responsibilities:
- Establish and maintain a state-of-the-art purification lab to enable rapid manufacturability assessment, purification process development, and scaleup for new biologics entities.
- Design experiments for purification unit operations; plan and execute purification process development studies with minimal supervision; support scaleup and implementation in internal and external GMP facilities.
- Collect and analyze laboratory data in compliance with data integrity policy; author and review experimental protocols and reports.
- Support and may lead process transfers to internal and contract manufacturing facilities for GMP and non-GMP drug substance production; provide person-in-plant oversight and technical support for manufacturing atypical event investigations.
- Support non-GMP pilot lab operations; review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports).
- Mentor junior team members on purification strategies, experimental design/execution, and process transfer.
- Lead purification platform development and evaluate/implement new technologies to enable fast first-in-human timelines.
- Improve workflows for screening lead molecules with optimal developability.
- Participate in cross-functional initiatives; adhere to budget, training, compliance, and safety requirements.
Basic Qualifications:
- Ph.D. (0+ years) or M.S. (4+ years) or B.S. (6+ years) in chemical engineering, bioengineering, biochemical engineering, biochemistry, or related field; industrial biologics purification development experience.
- Hands-on bench and pilot-scale chromatography, TFF, VF, and depth filtration.
- Pre-pivotal purification process development, scaleup, and implementation in GMP and non-GMP facilities.
- Statistics, design-of-experiments, and data analysis (e.g., JMP, Spotfire).
Preferred Qualifications:
- Excellent communication, technical writing, presentation, and creative problem-solving skills.
- Ability to collaborate and influence cross-functionally.
- Working knowledge of lab automation, data management/science, knowledge management, and data protection.
- Single-use manufacturing technology and cGMP guideline knowledge (plus).
- Passion for inclusion.
Compensation/Benefits (if eligible): Salary range $146,540.00–$189,640.00; may include discretionary bonus, stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions:
- For current Gilead employees and contractors, apply via the Internal Career Opportunities portal in Workday.
Key Responsibilities:
- Establish and maintain a state-of-the-art purification lab to enable rapid manufacturability assessment, purification process development, and scaleup for new biologics entities.
- Design experiments for purification unit operations; plan and execute purification process development studies with minimal supervision; support scaleup and implementation in internal and external GMP facilities.
- Collect and analyze laboratory data in compliance with data integrity policy; author and review experimental protocols and reports.
- Support and may lead process transfers to internal and contract manufacturing facilities for GMP and non-GMP drug substance production; provide person-in-plant oversight and technical support for manufacturing atypical event investigations.
- Support non-GMP pilot lab operations; review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports).
- Mentor junior team members on purification strategies, experimental design/execution, and process transfer.
- Lead purification platform development and evaluate/implement new technologies to enable fast first-in-human timelines.
- Improve workflows for screening lead molecules with optimal developability.
- Participate in cross-functional initiatives; adhere to budget, training, compliance, and safety requirements.
Basic Qualifications:
- Ph.D. (0+ years) or M.S. (4+ years) or B.S. (6+ years) in chemical engineering, bioengineering, biochemical engineering, biochemistry, or related field; industrial biologics purification development experience.
- Hands-on bench and pilot-scale chromatography, TFF, VF, and depth filtration.
- Pre-pivotal purification process development, scaleup, and implementation in GMP and non-GMP facilities.
- Statistics, design-of-experiments, and data analysis (e.g., JMP, Spotfire).
Preferred Qualifications:
- Excellent communication, technical writing, presentation, and creative problem-solving skills.
- Ability to collaborate and influence cross-functionally.
- Working knowledge of lab automation, data management/science, knowledge management, and data protection.
- Single-use manufacturing technology and cGMP guideline knowledge (plus).
- Passion for inclusion.
Compensation/Benefits (if eligible): Salary range $146,540.00–$189,640.00; may include discretionary bonus, stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions:
- For current Gilead employees and contractors, apply via the Internal Career Opportunities portal in Workday.