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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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Job Responsibility
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
Requirements
Doctorate degree & 2 years of Quality, Operations, Scientific, or Manufacturing experience
Master’s degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience
Bachelor’s degree & 6 years of Quality, Operations, Scientific, or Manufacturing experience
Associate's degree and 10 years of Quality, Operations, Scientific or Manufacturing experience
High School Diploma/GED and 12 years of Quality, Operations, Scientific or Manufacturing experience
Nice to have
B.S. or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field
6+ years working in a regulated environment
1+ year experience with authoring or review of market applications, IND, supplements or similar regulatory documentation
1+ year experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
Experience in Project Management in support of pharmaceutical development
Understanding of synthetic pharmaceutical bulk and drug product development, manufacturing, and analytical techniques
General knowledge of cGMP and US & international filing regulations, practices, and trends
Experience working on a cross-functional team in a matrix environment
Excellent written and verbal communication skills
A strong foundation in chemistry and experience with new synthetic modalities/technologies such as peptides, siRNA, new extended release formulations, and or combination products
What we offer
comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts