Principal Scientist, Analytical Lifecycle Management
$195,670–$253,220 year
On-siteFoster City, California, United States
Job Summary
Principal Scientist, Analytical Lifecycle Management leading QC strategy for late-stage biologics programs, acting as the primary QC representative on cross-functional CMC teams. Drive integrated QC program strategy across analytical method establishment, qualification and validation, method transfer, specification setting, stability and shelf-life strategy, reference standard strategy, and critical reagent planning. Lead authorship and regulatory submissions input, oversee external partners (CMDOs/CTLs), resolve complex technical and compliance issues, influence senior stakeholders, mentor matrixed colleagues, and provide strategic oversight of laboratory activities. Requires PhD or equivalent with 5+ years (or a Master's with 8+ or Bachelor's with 10+ years) in related disciplines; Mandarin ability preferred. Compensation range: $195,670 – $253,220 plus bonus/stock/benefits.
Required Qualifications
- PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, Biological Sciences, or a related scientific discipline and 5+ years of relevant experience; OR Master’s Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biological Sciences, or a related scientific discipline and 8+ years of relevant experience; OR Bachelor’s Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biological Sciences, or a related scientific discipline and 10+ years of relevant experience.
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