Contract Manufacturing Manager - Drug Substance
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Contract Manufacturing Manager - Drug SubstanceLive
What you will do
Lets do this. Lets change the world. In this vital Contract Manufacturing Manager role you will be a part of our Amgen Contract & Development Manufacturing (ACDM) team. This role will report to the Director of Small Molecule Drug Substance Manufacturing and will be based on main corporate campus in Thousand Oaks, CA. The Contract Manufacturing Manager will manage Contract Manufacturing Organizations (CMO) to deliver clinical or commercial drug substance. This manager will lead cross-functional teams to deliver products that meet vital 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.Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The biotech manufacturing professional we seek is a collaborative leader with these qualifications.Basic Qualifications:
Master's Degree & 3 years of Manufacturing & Operations experienceOr
Bachelor's Degree & 5 years of Manufacturing & Operations experienceOr
Associate's degree & 10 years of Manufacturing & Operations experienceOr
High school diploma/GED & 12 years of Manufacturing & Operations experiencePreferred Qualifications:
- Masters in Business Administration
- 3+ years of experience in small molecule 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%)
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
#Operations21Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Join UsIf 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.