Synthetics Principal Product Quality Leader
About the role
Join Amgens Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Responsibilities
- Provide effective, cross-functional quality leadership, and support PDT deliverables for late phase and commercial synthetic programs, including actions required for the PQT, APR, specification, comparability, and stability programs; site and method transfers; product quality impact statements for NCs; and PQ owned regulatory filing sections and RTQs
- Support science and risk-based evaluation of complex process and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues
- Demonstrate proficiency in oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies
- Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
Qualifications
- Bachelor's degree & 6 years of Quality, Operations, Scientific, or Manufacturing experience
- Doctorate degree & 2 years of Quality, Operations, Scientific, or Manufacturing experience
- Masters degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience