Sr. Manager, Contract Development and Manufacturing

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.

Senior ManagerContract Development and Manufacturing

What you will do

Lets do this. Lets change the world. In this dynamic role you will oversee Amgen Contract Development and Manufacturing (ACDM) sites. This role will focus on the process development and early clinical delivery. You will work with CDMOs to deliver on Amgens pipeline molecules. The ACDM team develops the external sourcing strategy for Amgens process development (PD) organization and drives implementation of the strategy and delivery across the development portfolio through executing activities according to Good Manufacturing Practices (cGMP) principles and the ACDM business practices. Responsibilities include:

• Leadership of 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.
• Identification of project optimization opportunities (timeline, budget, technical application), prioritization of a rolling portfolio of projects
• Leadership of operational and technical issue resolution, problem solving, corrective actions, and serve as a critical issue agent
• Building and maintaining strong and positive relationships with all Process Development functions to increase overall efficiency and success of programs
• Direct the identification, evaluation and selection of contract development and 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

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Manufacturing Management professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of Development and Manufacturing, or Operations experience OR Masters degree and 6 years of Development and Manufacturing, or Operations experience OR Bachelors degree and 8 years of Development and Manufacturing, or Operations experience OR Associates degree and 10 years of Development and Manufacturing, or Operations experience OR High school diploma / GED and 12 years of Development and Manufacturing, or Operations experience

Preferred Qualifications:

• Bachelors Degree in Science, Engineering
• Advanced degree in chemical, biological, or bio-molecular engineering, biochemistry or molecular biology is preferred
• Experience in Biologics process development (cell culture and/or purification).
• Experience collaborating with domestic and international CMO/CRO organizations
• Strong understanding of cGMP, Regulatory/CMC, legal, Quality requirements and import/export policies
• Proficiency in drug development and commercialization for biologic therapeutics
• Experience as team member/leader of cross-functional and matrixed teams including effective writing, presentation, organizational and interpersonal skills to address a broad scope of audiences
• Demonstrated discernment, high level critical thinking, and strong analytical skills with the ability to structure, pragmatically scope, and tackle complex problems
• Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence and performance management

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.