Process Development Associate Director - Cambridge, MA

Process Development Associate Director

Let's do this! Let's change the world! In this vital role you will manage an integrated group of cell culture and purification scientists working together to advance Amgen's rich, exciting and dynamic pipeline. Located at our Cambridge Massachusetts site, this scientific leadership position will be responsible for the development, characterization, scale-up and support of upstream and downstream drug substance processes to enable commercial advancement of programs. The Pivotal Biologics Drug Substance Process Development organization supports the commercialization of the drug substance manufacturing processes for all late-stage programs across the Amgen portfolio, enabling advancement of programs from Ph II / III clinical trials to marketing application and commercial launch. Lead a group to apply platform approaches and use solid problem-solving skills to rapidly solve development challenges and build robust processes with efficient experimentation. With Amgen's biology first approach, the position provides the unique opportunity of being able to work on a wide range of biologics molecules including antibodies, biosimilars, bispecifics, and other novel protein-based modalities. Develop and recruit strong and diverse teams and support staff in their career development. Leadership of matrix cross-functional teams that deliver robust drug substance commercialization data packages (including authoring of CMC sections of regulatory documents, interaction with regulatory agencies, support of technology transfers and working with various contract development and manufacturing organizations). Ideation, development, and deployment of differentiating technologies and establishing a culture of innovation. Expand Amgen's external eminence as well as representing Amgen in the external scientific community.