Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. Advancing science and helping patients - these dual passions are ingrained in our culture. They drive our work, our values, and everything we do at Amgen. For staff around the world, our mission to serve patients and our commitment to science makes Amgen a place where we can make a positive difference in people's lives while pursuing a challenging and fulfilling career. To foster a setting in which all staff may excel, we support a variety of growth opportunities-from training and education to expanding current job responsibilities.
Amgen is searching for a Contract Manufacturing Manager for our Contract Manufacturing team. This role will report to the Director of Product Quality and will be based on main corporate campus in Thousand Oaks, CA. The Contract Manufacturing Manager will manage contract organization(s) to deliver clinical or commercial drug products. This manager will lead cross-functional teams to deliver, from contract site, products that meet necessary quality, cost, and cycle time.
Key responsibilities include:
Manage contract organizations: Identify, evaluate and select appropriate contract sites to support needed production and testing; develop robust business processes and maintain reliable relationships with contract site management; assess industry trends, technology advancements, and contract site footprint.
Provide business support: Manage budget development, monitoring, and reporting; create and manage contracts - confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.; process purchase orders and invoices; actively manage and communicate forecasts to the sites and manage capacity planning.
Provide technology transfer and manufacturing support: Manage planning and coordination of product transfer to the contract site(s); develop budget, timeline and coordinate transfer team activities to achieve seamless product transfer to the contract site(s); drive risk management as part of transfer; lead site issue management and resolution; provide issue escalation to the right level
Provide performance monitoring: Track contract site performance and lead site operating review meetings; drive improvements at contract sites; daily duties will include owning and running appropriate meetings, managing procurement/payment of invoices, and managing communication/relationship with the contract site as well as internal management
Master's Degree & 3 years of Manufacturing & Operations experience
Bachelor's Degree & 5 years of Manufacturing & Operations experience
Associate's degree & 10 years of Manufacturing & Operations experience
High school diploma/GED & 12 years of Manufacturing & Operations experience
Master's in Business Administration
3+ years of experience in protein or API manufacturing environment
3+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
2+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
2+ years of project management experience leading multi-functional and multi-location team
Management of multiple teams
Strong oral and written communication skills, organizational and multi-tasking skills, excellent analytical skills, attention to detail, and strong ability to prioritize daily work based on changing business requirements
Ability to influence cross functional groups
Ability to think strategically and to provide clear direction and expectation to other team members in a highly dynamic environment
The ability for domestic and international travel (between 20 to 40%)
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
A little about us:
Amgen values the leadership, skills and passion for serving that veterans exemplify and our constant commitment to hiring the best starts here.