Contract Development & Manufacturing Manager

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission - to serve patients living with serious illnesses - drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Summary:

• Site lead for Contract Manufacturing Organizations (CMOs).
• Single point of accountability and interface between Amgen and assigned external partners.
• Drug Product, Finished Drug Product

Responsibilities:

:

• 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.

:

• Manage contract site performance, lead site operating review meetings;
• drive improvements at contract sites;
• sustain and improve the overall health of the business,
• Lead communication/relationship with the contract site as well as internal management.

:

• Lead a department-wide project from conception to implementation and close-out.
• Present to and obtain buy-in for value proposition of such projects to senior management.
• Provide oversight of all planning and coordination of product transfer activities to the contract site(s); develop, present, and obtain approval of budget, timeline and ensure execution of transfer team activities to achieve seamless product transfer to the contract site(s); ensure risk management initiatives are taking place as per RM plan;
• Lead site issue management and resolution; provide issue escalation to executive management.