Scientist 1, Analytical Development
Core
Qualify analytical test methods for Active Pharmaceutical Ingredients, intermediates, and final drug products using chromatography and physical characterization techniques.
Role type
Scientist 1, Analytical Development
Builds
Qualification of analytical methods for API, intermediates, and final drug products
Domain
Pharmaceutical manufacturing / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC/UPLC, GC, dissolution testing, Karl Fischer moisture analysis, TGA, DSC, PXRD, SEM, GMP compliance, technical writing
Preferred skills
None stated
Technologies
HPLC, UPLC, GC, TGA, DSC, PXRD, SEM, USP dissolution apparatus
Responsibilities
Perform and train others on analytical techniques; Develop cleaning verification methods and execute excipient compatibility/forced degradation studies; Troubleshoot and optimize analytical methods; Perform qualification studies for method transfer to Quality Control; Interpret data and maintain laboratory notebooks; Lead technical discussions with clients
Seniority
Junior, individual contributor