Manager - Amgen Contract Development and Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Contract & Development Manufacturing Manager

Live

What you will do

Lets do this. Lets change the world. In this vital role you will manage Amgens external network of development and manufacturing partners to ensure uninterrupted clinical and commercial supply for Amgens portfolio. The position will be in the Synthetic Small molecule Drug substance business unit of ACDM, and will focus on the early-phase and clinical portfolio. This is a key role in a high-performing cross-functional organization and will support technology / process development, supplier onboarding and relationship management, oversight of manufacturing activities for both non-GMP and GMP/clinical materials, and implementation of sourcing strategies (e.g., scope of work, proposal request execution, participation in site selections).

The Amgen Contract Development and Manufacturing organization sits within External Supply in Operations, and is responsible for developing and implementing the external sourcing and manufacturing strategy for Amgens portfolio, from early phase through commercial delivery. Amgen Contract Development and Manufacturing leverages a network of global assets to create exceptional value for Amgen and deliver vital medicines for our patients.

The successful candidate will demonstrate a strong desire to work in a fast-paced environment leading accelerated programs, and be able to quickly adapt strategies in support of the dynamic early-phase portfolio. Understanding of commercial supply to develop a robust supply chain is a plus. Key responsibilities of this role include:

• Key point of contact / interface with CDMOs / CROs, managing external synthetics and/or process chemistry-focused projects, spanning development and clinical manufacture in close collaboration with Amgens technical and functional leads (Drug Substance, Analytical, Quality, Supply Chain, and others)
• Ability to work under minimal guidance to manage multiple assignments and/or business processes
• Build and maintain positive relationships with all Process Development and Operations 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 and cross functional leads
• Ensure projects and/or programs meet results, compliance, speed, quality, and cost
• Budget management, including purchase orders, financial forecasting, and associated finance cycles for externalization, adhering to financial targets and systems
• Establish and maintain external collaborations and monitor supplier performance to continuously improve efficiency and effectiveness of suppliers
• Identify project optimization opportunities (e.g., timeline, budget, technical completion)
• Present analyses and recommendations to Senior Management
• Occasional domestic and international travel to support project results
• Opportunity to lead external projects in areas beyond synthetic small molecule Drug Substance, including hybrid modalities, based on portfolio needs

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The strategic professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

• Doctorate degree OR
• Masters degree and 3 years of relevant industry experience, within a scientific and/or cGMP manufacturing environment Or
• Bachelors degree and 5 years of relevant industry experience, within a scientific and/or cGMP manufacturing environment Or
• Associate's degree and 10 years of relevant industry experience, within a scientific and/or cGMP manufacturing environment Or
• High school diploma/GED and 12 years of relevant industry experience, within a scientific and/or cGMP manufacturing environment

Preferred Qualifications:

• Advanced degree in chemistry or chemical engineering
• Demonstrated understanding of drug development and commercialization for synthetic therapeutics, including route scouting, raw material and starting material sourcing, API/drug substance manufacture, process development, process engineering, and process characterization
• 2+ years of experience working with domestic and international CDMOs/CROs
• 2+ years 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 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
• Strong knowledge in the use of project management methodologies and tools, resource management practices and change management techniques

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.