Career Category

Job Description

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

What you will do:

Let’s do this. Let’s change the world. In this vital role you will join the Synthetic Drug Substance Amgen Contract Development & Manufacturing (ACDM) team. This group was built to support sourcing strategy and drive the implementation of this strategy across the manufacturing and development portfolio.

You will work with CMOs to deliver supply of commercial and clinical manufacturing and provide business management oversight. Lead the implementation of sourcing initiatives and manage a variety of external projects engaging international suppliers.

The responsibilities of this role include:

Site lead for low-risk Contract Manufacturing Organizations (CMOs). 
Single point of accountability and interface between Amgen and assigned external partners.

Manufacturing operations: Develop and lead robust business processes, maintain reliable relationships with contract site management; assess industry trends, internal network, and technology advancements as tools to improve contract site performance. 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.; monitor and improve financials with CMO; actively manage and communicate forecasts to the sites and manage capacity planning. Drive operational excellence and champion change.

Site performance monitoring: Manage contract site performance using lean tools and PDCA, lead site operating review meetings; drive improvements at contract sites; sustain and improve the overall health of the business, and lead communication/relationship with the contract site as well as internal management.

Additional activities:

• Project leadership for synthetics and/or process chemistry-focused (small molecule, synthetic peptides, and oligonucleotides) external projects.
• Work under minimal guidance to manage of multiple assignments and/or business processes
• Build and maintain positive relationships with all internal functions to increase overall efficiency and success of programs
• Supplier evaluation and outsourcing management including site selection activities
• Develop scopes of work in close partnership with technical leads
• Ensure projects and/or programs meet results, compliance, speed, quality, and cost
• Manage purchase orders, financial forecasting, and associated budget for externalization to adhere to financial targets and systems
• Establish and maintain external collaborations and monitor supplier performance to continuously improve efficiency and effectiveness of suppliers

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 3 years of Operations experience

OR

Bachelors degree and 5 years of Operations experience

OR

Associate's degree and 10 years of Operations experience

OR

High school diploma/GED and 12 years of Operations experience

Preferred Qualifications:

• Advanced degree in engineering or science
• Demonstrated understanding of manufacturing, development and commercialization for synthetic therapeutics, raw material and starting material procurement
• API/drug substance manufacture, process development, process engineering, and process characterization
• Experience working with d international CMOs/CROs
• Solid understanding of cGMP, Regulatory/CMC, legal, quality requirements, and import/export policies
• Self-starter with a high-level of comfort with ambiguity and complexity 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