Senior Research Chemist (Drug Product) - Eurofins CDMO Alphora, Inc.
Core
Lead analytical method development, transfer, and validation for oral drug products while supporting QC release, stability studies, and investigations.
Role type
Senior Research Chemist (Drug Product)
Builds
Analytical methods, specifications, and GMP-compliant drug product data
Domain
Pharmaceutical manufacturing (CDMO) / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Analytical testing & validation)
Required skills
Analytical method development, Method transfer, Validation (phase-appropriate), GMP/GLP/ICH compliance, Instrument troubleshooting (HPLC, GC, KF), Stability study design, Investigation of OOT/OOS/Deviations, SOP authoring
Preferred skills
Mentoring junior staff, Continuous improvement, Problem-solving
Technologies
HPLC, GC, KF
Responsibilities
Lead analytical method development, transfer, and validation; Support QC release testing, stability studies, and investigations; Author and review GMP documentation; Troubleshoot and maintain analytical instruments; Ensure compliance with cGMP, GLP, and regulatory guidelines; Mentor or oversee junior staff
Seniority
Senior, hands-on IC with potential for supervision
