Contract Manufacturing Specialist
Contract Manufacturing Specialist
Japan - Tokyo Apply NowHOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
Contract Manufacturing Specialist
Live
What you will do
The Specialist in Manufacturing at Amgen provides technical support to the manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. They liaise between different departments to ensure a smooth manufacturing process and compliance with quality standards.
Specialist - Manufacturing
Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure Amgen Contract Manufacturing (ACM) work cell (hub) success.
Responsibilities:
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.
Win
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.
Basic Qualifications:
Doctorate degree
OR
Master’s degree and 3 years of contract manufacturing management experience
Or
Bachelor’s degree and 5 of contract manufacturing management experience
Or
Associate’s degree and 10 years of contract manufacturing management experience
Or
High school diploma / GED and 12 years of contract manufacturing management experience
Preferred Qualifications:
Bachelor’s in Business Administration, Engineering, or Science-related field
Fluent in English and Japanese
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
Thrive
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
Apply now
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.com
Equal 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.
