HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youâre part of something bigger, itâs because you are. At Amgen our shared missionâto serve patientsâdrives all that we do. It is key to our becoming one of the worldâs leading biotechnology companies. We are global collaborators who achieve togetherâresearching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. Itâs time for a career you can be proud of. Join us.
Contract Development and Manufacturing Senior Manager
Live
What you will do
Letâs do this. Letâs change the world. In this vital role you will oversee Amgen Contract Development and Manufacturing (ACDM) sites through executing activities according to Good Manufacturing Practices (cGMP) principles and the ACDM business practices.
This role will require the candidate to be regionally based in Japan, with strong technical communication skills required in both Japanese and English.
Responsibilities:
Project leadership for Amgen modalities (Synthetic DP/FDP, Biologics DP/FDP) external projects spanning development, clinical and commercial manufacture in close coordination with Amgenâs technical and functional leads (Drug Substance, Analytical, Quality, Supply Chain, Global Strategic Sourcing and others). Opportunity to pivot between modalities for career development and greater exposure to Amgen products. Develop scopes of work in close partnership with functional leads (Drug Substance, Analytical, Quality, Supply Chain, Global Strategic Sourcing and others).
Build and maintain positive relationships with Process Development and other functions within and outside of Operations to increase overall efficiency and success of programs.
Work under minimal guidance to manage of multiple assignments and/or business processes.
Establish and maintain external collaborations and monitor supplier performance to continuously improve efficiency and effectiveness of suppliers.
Manage purchase orders, financial forecasting, and associated budget for externalization to adhere to financial targets and systems
Ensure projects and/or programs meet results, compliance, speed, quality, and cost. Identifying project optimization opportunities (timeline, budget, technical implementation).
Contribute to ACDM knowledge development including assessment of industry trends, technology advancement, and contract manufacturing landscape. Ability to understand legal contracts to support negotiation process with suppliers.
Drive risk management, operations excellence, and other Operations initiatives.
Travel 20%: Domestic and International
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic manufacturing professional we seek has the following qualifications:
Basic Qualification:
Doctorate degree and 2 years of Manufacturing or Operations experience
OR
Masterâs degree and 6 years of Manufacturing or Operations experience
OR
Bachelorâs degree and 8 years of Manufacturing or Operations experience
OR
Associateâs degree and 10 years of Manufacturing or Operations experience
OR
High school diploma / GED and 12 years of Manufacturing or Operations experience
Candidates must demonstrate professional fluency in English, including strong written and verbal communication skills.
Preferred Qualifications:
8+ years proven experience in Pharmaceutical Manufacturing. Specifically, Understanding of drug development, manufacturing and commercialization for Amgen modalities (Synthetic DP/FDP, Biologics DP/FDP). Demonstrated ability to pivot between modalities or phase of drug lifecycle ie. early vs. late stage, clinical versus commercial
8+ years working knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
5+ years demonstrated ability working with external parties and/or leading cross-functional teams for clinical and/or commercial products
3+ years of project management experience leading multi-functional and multi-location team
Experience interacting with domestic and international suppliers, including import and export policies. Preferred experience with CDMOs/CROs
Self-starter, comfortable with ambiguity and complexity and the ability to successfully multi-task while consistently delivering quality results.
Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence and performance management.
Business acumen, high level strategic thinking, and strong analytical skills with the ability to structure, pragmatically scope, and solve complex problems.
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 teammatesâ 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.
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