Senior Research Associate, Analytical Operations
Core
Conduct GMP testing and analytical method development to support clinical OSD manufacturing and pilot plant operations.
Role type
Senior Research Associate, Analytical Operations
Builds
Clinical drug substances and products for pilot plant manufacturing
Domain
Pharmaceutical manufacturing / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, UPLC/HPLC, Gas Chromatography, Ion Chromatography, Dissolution testing, Karl Fischer, Differential Scanning Calorimetry, Particle Size Distribution, X-Ray Powder Diffraction, UV-Vis spectroscopy, SOP authoring, CAPA management, method validation, regulatory inspection support
Preferred skills
None stated
Technologies
UPLC, HPLC, Gas Chromatography, Ion Chromatography, Dissolution testers, Karl Fischer titrators, DSC, Particle Size Analyzers, XRD, UV-Vis spectrophotometers
Responsibilities
Conduct GMP testing for raw materials, intermediates, in-process controls, and cleaning samples; Test method feasibility for drug product pilot plant cleaning samples; Analyze samples using various analytical techniques; Perform verification and data review to ensure compliance with SOPs and protocols; Author/Review laboratory investigation records, deviations, and CAPA; Provide on-the-job training of analytical techniques or GMP training to new hires or junior staff; Write/Revise protocols, methods, SOPs, and reports; Lead projects and support cross-functional activities such as instrument/system upgrades and method validation; Conduct GMP testing for release, stability, and method transfer for clinical drug substances and products; Serve as a Subject Matter Expert in analytical techniques or processes, participate in working groups, assess pharmacopeial changes, and support internal audits and regulatory inspections
Seniority
Senior, hands-on IC
