Team Leader
Current• Lead a team of five scientists engaged in the development of analytical methods and the analysis of injectable drugs• Manager of the ICP-MS core facility• Address deficiency letters issued by the FDA• Design and conduct stability studies as per ICH guidelines for drug products • Conduct investigations into out of specification results• Write and update instrument SOPs, risk assessments for extractables and leachables, justification of specifications, API assessments• Transfer analytical methods from R&D to the manufacturing sites