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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 read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Contract Development and Manufacturing Senior Manager

Live

What you will do

Let’s do this. Let’s 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.

In this role you will manage Amgen’s external network of development and manufacturing partners to ensure uninterrupted clinical and commercial supply for Amgen’s portfolio. This is a key role in a high-performing cross-func+organization and will support technology / process development, supplier onboarding and relationship management, oversight of manufacturing activities for both non-GMP and GMP/clinical materials, and implementation of sourcing strategies (e.g., scope of work, proposal request execution, participation in site selections).

The Amgen Contract Development and Manufacturing organization sits within External Supply in Operations and is responsible for developing and implementing the external sourcing and manufacturing strategy for Amgen’s portfolio, from early phase through commercial delivery. Amgen Contract Development and Manufacturing leverages a network of global assets to create exceptional value for Amgen and deliver vital medicines for our patients. The successful candidate will demonstrate a strong desire to work in a fast-paced environment leading accelerated programs and be able to quickly adapt strategies in support of the dynamic environment. Understanding of commercial supply to develop a robust supply chain is a plus.

Key responsibilities of this role include:

Lead cross-functional teams with clear accountability for performance and ensure the quality, cost, and delivery of products from Amgen's Contract Development and Manufacturing sites are consistently met, as well as lead issue resolution, problem solving and serve as an escalation agent.

Direct the identification, evaluation and selection of contract manufacturers as well as the planning and coordination of product transfers to contract sites.

Manage budget development, monitoring and reporting; ensure cost of production targets are met; and actively oversee forecasting, capacity planning and project management.

Ensure metrics are in place to measure, track the performance of the contract sites, and lead external or internal operating review meetings.

Drive continuous improvement at contract manufacturing sites by building robust business processes and reliable relationships with contract site management, and working closely with internal quality, supply chain and process development organizations to ensure contract manufacturing sites are monitored and that corrective actions are implemented in a timely fashion.

Contribute to ACDM knowledge development including assessment of industry trends, technology advancement, and contract manufacturing landscape.

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:

Preferred Qualifications:

Bachelor’s in Business Administration, Engineering or Science

8+ years proven experience in protein, Active Pharmaceutical Ingredients, Drug Substance, Drug Product, or packaging manufacturing environment

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

Self-starter with a high-level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results

Experienced team member of cross-functional and matrixed teams including effective writing, presentation, and interpersonal skills to address a broad scope of audiences

An eye for business, high-level critical thinking, and strong problem-solving skills with the

ability to structure, pragmatically scope, and solve problems

Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence, and performance management

Strong knowledge in the use of project management methodologies and tools, resource management practices and change management techniques

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.