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Job Description

HOW 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.

Director of Contract & Development Manufacturing

Live

What you will do

Let’s do this. Let’s change the world.

The Director, ACDM Biologics is expected to provide leadership for Amgen Contract Development & Manufacturing Organization and to manage specific contract organization(s) to deliver clinical and commercial biologics drug substance. The staff is to manage site managers that are expected to lead cross-functional teams to, deliver from contract site, products that meet necessary quality, cost, and cycle time. Key responsibilities to deliver through site managers include:

• Manage multiple 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 biologics 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. Ensure delivery metrics are achieved and Quality records timelines are met. Drive improvements at contract sites.

• Project Management: Ability to lead a department-wide project from conception to implementation and close-out. Ability to provide value proposition of such projects to senior management.

Routine duties will include managing contract site selection, cross-functional strategy with process development/quality/supply chain, management review, operating review, group budget, contract site and staff performance, and managing communication/relationship with the contract site as well as internal management.

Domestic and international travel will be required (between 10 to 30%).

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree and 4 years of Manufacturing experience OR

• Master’s degree and 7 years of Manufacturing experience OR

• Bachelor’s degree and 9 years of Manufacturing experience

Preferred Qualifications:

• Masters in Business Administration

• 7 years of experience in biologics manufacturing environment

• 7 years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles

• 3 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

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also 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.

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