Contract Manufacturing Manager
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 Development and Manufacturing ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will lead:
Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
Site performance monitoring: Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.
Project Management and Technology transfers: Follow-up and track activities in a department-wide project from conception to implementation and close-out. Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.Competencies
- Demonstrated matrix management and influencing skills
- Manufacturing and cGMP knowledge / experience
- Demonstrated negotiation skills
- Operational Excellence proficiency and ability to drive continuous improvement
- Financial/budgeting knowledge and business acumen
- Proficient project management skills
- Problem-solving and critical thinking
- Understanding of contractual requirements
- Technical writing and multi-level communication skills
- Demonstrated ability to lead effectively in collaborative/team environment
- Demonstrated ability to take initiative, drive action, and work under minimum supervision
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The management professional we seek is a collaborative cross-functional leader with these qualifications.
Masters degree and 3 years of contract manufacturing management experience
Bachelors degree and 5 of contract manufacturing management experience
Associates degree and 10 years of contract manufacturing management experience
High school diploma / GED and 12 years of contract manufacturing management experience
- Bachelors in Business Administration, Engineering, or Science-related field
- 5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment
- 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
- 2+ years of project management experience leading multi-functional and/or multi-location team
- 1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
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.
careers.amgen.comEqual 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.