R&D/Mfg Scientist II-Reviewer
Core
Independently performs complex cGMP analytical data reviews, supports validation testing, and ensures laboratory integrity compliance for drug products and raw materials.
Role type
Senior IC R&D/Mfg Scientist (Analytical Data Review)
Builds
Supports validation of analytical methods, protocols, and reports for pharmaceutical drug products and raw materials.
Domain
Pharmaceutical manufacturing / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP data review, HPLC, UV, FT-IR, Karl Fischer Titration, method validation, regulatory compliance (ICH, USP/EP, GMP), data trending, LIMS/SLIM system usage, OOS investigation support, SOP authoring/reviewing
Preferred skills
ELISA, CGE, Dot-Blot, IEF, analytical method development, transfer, and verification, assay/impurity/potency testing
Technologies
Empower, LIMS, SLIM, Microsoft Office
Responsibilities
Perform cGMP analytical data review for various techniques; Verify data entry into designated software systems; Trend data to ensure requirements are met; Assist in OOS investigations, deviations, and change controls; Author or review technical reports, protocols, and validation summaries; Communicate project status and concerns to management; Support in-process, release, and stability testing.
Seniority
Mid-Senior, hands-on IC
