Role Responsibilities:Utilize PAT analytical instrumentation (e.g., NIR, FBRM Instruments, APC Software) for manufacturing campaigns: including preparation, installation, calibration, and performance checks.Monitor instrumentation output during campaigns using advanced process control software & real-time dashboards & analytics.Ability to work in a GLP or GMP environment with appropriate documentation and safety practices.Responsible for utilizing analytical methodologies, systems, and processes to support GMP release and stability testing of clinical supplies for drug substance and drug product, throughout all phases of development. This may include excipient, packaging, and post packaging supportAnalytical testing would include: compendial testing (e.g., excipients/packaging release testing), disintegration, dissolution, HPLC/UPLC, SFC, generic testing (e.g., solvents, water, ash, titrations, heavy metals, ICP/MS, UV) and compound specific methodsSet up and analysis of drug substance and drug product stability samples
