Takeda Manufacturing USA Inc. – $161,221.00/Year

Required skills Develop formulations and manufacturing processes for various dosage forms including the analytical testing method development; manage internalexternal manufacturing organizations for clinical trial materials and commercial products; experience in communicating CMC strategy, tactics and resulting data with regulatory agencies such as FDA, EMA and PMDA by utilizing extensive knowledge of current Good Manufacturing Practices cGMP, ICH Guidelines, other pertinent national regulations, and compendial requirements; Demonstrate leadership on drug product and combination device project teams, influencing and guiding internal and external stakeholders to accomplish efficient and timely product pipeline transfers from CMC to commercial partners; demonstrate ability to identify technical, budgetary, and schedule risks for complex multidisciplinary programs and propose appropriate risk response strategies. Up to 25 travel required.