Overview In this role you will provide technical leadership for analytical method lifecycle management across commercial and late-stage programs. You will partner with QC, QA, Regulatory, and CMOs to ensure robust analytical performance, compliance, and inspection readiness. You will drive method transfer, validation, troubleshooting, investigations, and continuous improvement, focusing on chemistry-based methods and chromatography. This position offers an opportunity to shape analytical strategies in a fast-paced, cross-functional setting and contribute to regulatory submissions and product quality.
Compensation / Benefits- competitive healthcare benefits
- well-being resources (fitness, mindfulness, mental health)
- family planning benefits (fertility, adoption, surrogacy)
- generous paid time off
- discretionary bonus or equity opportunities
- location-specific perks
Responsibilities- Lead chemistry-focused analytical method transfers, validations, verifications, and comparability assessments across internal and external labs (HPLC/UPLC, compendial methods)
- Provide technical expertise for method performance and lifecycle management of chemistry-based analyses
- Collaborate cross-functionally to identify root causes and implement corrective actions
- Support laboratory investigations, OOS/OOT/atypical result assessments and CAPA development
- Author/review/approve technical documents (protocols, reports, SOPs, specifications) and ensure inspection readiness
- Support QC networks and external testing partners, including CMOs, for method implementation and execution
- Monitor analytical performance metrics; drive data-driven process improvements
- Assist with regulatory submissions and health authority inspections as required
- Contribute to harmonization of practices across sites and support compendial requirements (USP, etc.)
- Support digital/data-driven initiatives for analytical operations
Key requirements- Bachelor's degree with 5+ years of relevant industry experience, or Master's with 3+ years, or PhD with 0-2 years in Analytical Chemistry or related field
- Experience supporting analytical method transfer, qualification, validation, verification, or lifecycle management in GMP/pharma
- Experience authoring/reviewing protocols, reports, specs, test methods, investigations, SOPs
- Working knowledge of GMP, data integrity, and pharmaceutical quality systems
- Experience with laboratory investigations (OOS, OOT, deviations)
- Strong analytical data analysis and scientific judgment; cross-functional collaboration experience
- Strong communication across cross-functional teams
- Analytical problem solving and critical thinking
- Attention to detail and commitment to quality
- HPLC/UPLC expertise; chromatographic techniques; compendial methods
- Troubleshooting analytical methods and instrumentation
- Understanding of method validation, transfer, qualification, verification, lifecycle management
