PDS AD&GMP Scientist I
Core
Analytical Scientist performing method development, transfer, validation, and routine testing of raw materials, in-process, and finished products in a cGMP pharmaceutical environment.
Role type
Analytical Scientist (cGMP)
Builds
Supports product development (API and Drug Product) and stability testing for clients.
Domain
Pharmaceutical manufacturing / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC, GC, FT-IR, UV-Spectrophotometer, Viscosimeter, Empower software, cGMP compliance, SOP adherence, OOS investigation, data documentation (ALCOA), method validation, method transfer, stability testing, raw material testing, formulation testing
Preferred skills
MS degree in science, 2-3 years lab experience, pharmaceutical/biotech environment experience
Technologies
HPLC, GC, FT-IR, UV-Spectrophotometer, Viscosimeter, Empower, MS Office
Responsibilities
Conduct independent analysis using HPLC/UPLC/FT-IR/UV-Spectrophotometer/Viscosimeter following SOPs; Perform analytical method development, transfer, and validation; Execute routine and stability testing on APIs, formulations, and finished products; Compile data and prepare reports for documentation; Investigate and report Out of Specification (OOS) results; Coordinate analysts for testing activities; Assist in preparation of scientific documents (methods, protocols, SOPs); Maintain laboratory materials and equipment; Perform basic troubleshooting for system suitability failures.
Seniority
Junior to Mid-level, hands-on IC
