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Job Summary

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:

1) 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.

2) 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.

3) 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.

4) 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.

5) 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%).

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

Location:

Flexspace with home location in Dun Laoghaire, Ireland

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.