North AmericaFull TimeEngineering
Remotely
method validationhplcuplcgcdissolutionresidual impuritieselemental impuritiesgenotoxic impurities
Job Description
📋 Description
- Global analytical lifecycle owner for small-molecule products
- Lead analytical strategy across major markets
- Partner with QA, Regulatory, supply, and tech partners
- Drive method updates, validation, verification, and transfers
- Own release specs, stability, and robustness improvements
- Support regulatory submissions and inspections
🎯 Requirements
- Bachelor’s + 10+ years biopharma exp; advanced degree preferred
- Leadership in GMP QC/analytical sciences for commercial products
- Expertise in HPLC/UPLC, GC, dissolution, residual and elemental impurities
- Know-how in validation, stability trending, statistics, and lifecycle management
- Data integrity, risk-based decisions, and regulatory documentation skills
- Strong writing, communication, and cross-functional collaboration
🎁 Benefits
- Base salary $168,000–$228,000
- Annual bonus eligibility and equity opportunities
- Comprehensive medical, dental, vision
- 401(k) with matching; FSA/HSA options
- Life insurance and paid time off
- Remote-based position in the United States
