Sr Scientist, Purification Process Development (Pivotal & Commercial)
$169.32k - $219.12kGilead
Gilead Sciences seeks a senior scientist to lead purification process development for biologic therapeutics during pivotal and commercial stages. The role involves designing experiments, managing development strategies, supporting technology transfer, and collaborating across cross-functional teams.
Responsibilities
- Design and execute purification process development experiments including chromatography, TFF, virus filtration, and clearance studies
- Lead process characterization strategy, risk management, and regulatory documentation for pivotal and commercial programs
- Conduct technology transfer activities and support clinical resupply in partnership with manufacturing teams
- Author and review technical documents, regulatory submissions, and SOPs with attention to data integrity
- Represent department on cross-functional teams and mentor junior scientists on development strategies
Requirements
- Ph.D. in chemical engineering, biochemistry, or bioengineering with 2+ years experience
- Or M.S. with 6+ years in relevant scientific discipline
- Or B.S. with 8+ years in relevant scientific discipline
- Experience in pivotal-stage purification process development and GMP implementation
- Technology transfer experience at 2-25 kL scale with regulatory knowledge
- Strong technical writing, communication, and problem-solving skills
- Experience with statistics, design-of-experiments, and data analysis tools
Compensation: $169,320.00 - $219,120.00 base
Vacancy posted 9 days ago
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