Principal Scientist Analytical Lifecycle Management
Overview
Lead Quality Control for late-stage biologics programs at Gilead, driving integrated QC strategies across CMC teams. Own analytical control strategy from method establishment to commercialization readiness. Differentiate by leveraging deep regulatory expertise and cross-functional leadership.
What You'll Do11
- 1Serve as QC Lead for late-stage clinical biologics programs, acting as primary QC representative on cross-functional CMC teams
- 2Provide QC leadership technical direction and risk-based decision-making to advance biologics drug substance and drug product programs
- 3Own integrated QC program strategy covering analytical method establishment qualification validation method transfer specification setting stability shelf-life reference standards critical reagent planning
- 4Lead authorship technical review strategic input for regulatory submissions ensuring scientific rigor and global GMP alignment
- 5Oversee external partners including CDMOs and CTLs managing method readiness testing execution data quality laboratory investigations quality events
- 6Anticipate resolve complex technical quality compliance issues using scientific judgment cross-functional influence matrixed team alignment
- 7Provide technical mentorship coaching fostering scientific rigor accountability collaboration high-quality QC deliverables
- 8Strategic oversight laboratory activities including technical troubleshooting method readiness assessments testing strategy data interpretation
- 9Create Inclusion model diversity embed value in team management develop talent understand employee skills aspirations coach growth empower teams align goals purpose hold accountable
- 10Influence cross-functional outcomes translate complex QC topics senior stakeholders drive timely decisions
- 11Provide strategic oversight of lab activities technical troubleshooting method readiness assessments testing strategy data interpretation
Requirements10
- 1PhD in Chemistry Biochemistry Pharmaceutical Sciences Biological Sciences OR Master's degree equivalent with 5+ years relevant experience
- 2Master's degree equivalent with 8+ years relevant experience OR Bachelor's degree equivalent with 10+ years relevant experience
- 3Extensive experience in Quality Control Analytical Development CMC technical roles supporting biologics drug substance/drug product programs in GMP environment
- 4Demonstrated leadership late-stage biologics QC strategy analytical method establishment qualification validation method transfer specification setting stability shelf-life justification reference standards critical reagents
- 5Strong understanding global GMP expectations ICH guidance compendial requirements regulatory expectations biologics analytical control strategy QC lifecycle management
- 6Authoring reviewing technical input QC-related regulatory submissions health authority responses comparability packages late-stage CMC documentation
- 7Proven ability influence cross-functional teams communicate complex technical topics to senior stakeholders drive alignment make risk-based decisions
- 8Experience working independently matrixed environment anticipate program risks resolve complex technical compliance issues provide strategic recommendations
- 9Oversee external partners CDMOs CTLs experience with contract testing laboratories
- 10Excellent written verbal communication skills mentor colleagues represent QC perspectives produce high-quality technical documentation
Salary Insight
$196 - $253k per year
Location
Required Skills
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