Sr Director, Contract Development & Manufacturing - Drug Substance, Synthetics

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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.

Sr Director, Contract Development & Manufacturing - Drug Substance, Synthetics

What you will do

Let’s do this. Let’s change the world. In this vital role you will oversee the strategic and operational aspects of Synthetic Drug Substance manufacturing and development activities being conducted at Amgen’s Contract Manufacturing Organizations (CMO’s) The individual in this role will lead a global team of Site Managers and have direct impact on site selections, technology transfer, process scale-up, process characterization, process validation, clinical and commercial manufacturing needs, ensuring products meet necessary standards of quality, cost, compliance and cycle time.

• Manage multiple CMOs: 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.
• 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.
• Provide technology transfer and synthetics 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.
• 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.
• 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.
• 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.
• This is a highly cross functional role and the individual will partner with Quality, Supply Chain, Process Development and Program management to ensure alignment and achievement of company goals and objectives
• Domestic and international travel will be required between 10 to 30%.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go-getter with these qualifications.

Basic Qualifications:

• Doctorate degree and 5 years of Synthetic Chemical Manufacturing and/or Process Development experience
• OR
• Master’s degree and 10 years of Synthetic Chemical Manufacturing experience
• OR
• Bachelor’s degree and 12 years of Synthetic Chemical Manufacturing and/or Process Development experience
• In addition to meeting at least one of the above requirements, candidates must have a minimum of 5 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• 10+ years of experience in a synthetic manufacturing environment
• 10+ years in roles requiring knowledge of c