Senior Associate II - Analytical Development
Core
Develop and validate analytical methods for parenteral radiopharmaceutical products, including stability testing and method transfer to support product development and commercialization.
Role type
Senior Associate II, Analytical Development (IC)
Builds
Radiopharmaceutical therapies for oncology patients
Domain
Biopharmaceuticals / Radiopharmaceuticals / Analytical Chemistry
Required skills
UHPLC, HPLC, GC, TLC, ICP, LC-MS, Gamma Spectrometry, Alpha Spectrometry, GMP compliance, method validation, root cause analysis, laboratory instrumentation software
Preferred skills
Parenteral GMP manufacturing, radiopharmaceutical handling, radioactive materials handling
Technologies
UHPLC, HPLC, GC, TLC, ICP, LC-MS, Gamma Spectrometry, Alpha Spectrometry
Responsibilities
Develop and validate analytical methods for radiopharmaceutical products; Participate in method transfer activities from CDMO or research facilities; Prepare analytical test methods and validation protocols; Troubleshoot analytical issues and implement corrective actions; Maintain laboratory documentation and SOPs; Perform instrument qualification and calibration; Ensure compliance with GMP and radiation safety programs.
Seniority
Mid-level, hands-on IC