Senior Manager Contract Development and Manufacturing

at  Amgen

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

BASIC QUALIFICATIONS:

• Doctorate degree and 2 years of engineering, science or business management experience OR
• Master’s degree and 4 years of engineering, science or business management experience OR
• Bachelor’s degree and 6 years of engineering, science or business management experience OR
• Associate’s degree and 10 years of engineering, science or business management experience OR
• High school diploma/GED and 12 years of engineering, science or business management experience

PREFERRED QUALIFICATIONS:

• Advanced degree in engineering or science
• Demonstrated understanding of drug development and commercialization for synthetic therapeutics, particularly synthetic peptides and oligonucleotides. This includes route scouting, raw material and starting material procurement, API/drug substance manufacture, process development, process engineering, and process characterization
• Experience working with domestic and 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 and the ability to multi-task while consistently delivering quality results
• Experienced leader and team member of cross-functional and matrixed teams
• Effective written, presentation, organizational, interpersonal, and influencing skills to address a broad scope of audiences including demonstrated ability to drive decision-making
• Demonstrated quantitative and qualitative skills to support business process development, financial analysis, continuous improvement, operational excellence, performance management, and product lifecycle management
• Proven business acumen with high-level strategic thinking
• Strong problem-solving skills with the ability to structure, pragmatically scope, and solve complex problems

Let’s do this! Let’s change the world! In this vital role, you will be part of Amgen’s Contract Development & Manufacturing (ACDM) team. This group was built to support Process Development’s sourcing strategy and drive the implementation of this strategy across the development portfolio. In this position, you will work with CRO/CMO’s to support development, clinical/commercial manufacture, and business management. You will also lead the implementation of sourcing initiatives and manage a variety of external projects engaging domestic, international, and emerging market suppliers.

The responsibilities of this role include:

• Project leadership of synthetic peptide and oligonucleotide external projects spanning development and clinical/commercial manufacture in close coordination with internal technical stakeholders
• Ability to work under minimal guidance to manage of multiple assignments and/or business processes
• Ability to build and maintain positive relationships with internal technical stakeholders to increase overall efficiency and success of programs
• Supplier evaluation and outsourcing management including site selection activities
• Development of scopes of work in close partnership with technical leads
• Assurance that projects and/or programs meet results, compliance, speed, quality, and cost
• Management of purchase orders, financial forecasting, and associated budget for externalization to adhere to financial targets and systems
• Ability to establish and maintain external collaborations to monitor supplier performance, continuously improve efficiency, and ensure effectiveness of suppliers
• Ability to independently identify project optimization opportunities (e.g., timeline, budget, technical completion)
• Ability to clearly present analyses and articulate recommendations to Senior Management
• Occasional domestic and international travel to support project results