Contract Development and Manufacturing Senior Manager
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.
Contract Development and Manufacturing Senior Manager
What you will do
Let’s do this! Let’s change the world! In this vital role you will oversee Amgen Contract Development and Manufacturing (ACDM) sites through executing activities according to Good Manufacturing Practices (cGMP) principles and the ACDM business practices.
In this role you will manage Amgen’s external network of development and manufacturing partners to ensure uninterrupted clinical and commercial supply for Amgen’s 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 Amgen’s 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 environment. Understanding of commercial supply to develop a robust supply chain is a plus.
Key responsibilities of this role include:
Lead cross-functional teams with clear accountability for performance and ensure the quality, cost, and delivery of products from Amgen's Contract Development and Manufacturing sites are consistently met, as well as lead issue resolution, problem solving and serve as an escalation agent.
Direct the identification, evaluation and selection of contract manufacturers as well as the planning and coordination of product transfers to contract sites.
Manage budget development, monitoring and reporting; ensure cost of production targets are met; and actively oversee forecasting, capacity planning and project management.
Ensure metrics are in place to measure, track the performance of the contract sites, and lead external or internal operating review meetings.
Drive continuous improvement at contract manufacturing sites by building robust business processes and reliable relationships with contract site management, and working closely with internal quality, supply chain and process development organizations to ensure contract manufacturing sites are monitored and that corrective actions are implemented in a timely fashion.
Contribute to ACDM knowledge development including assessment of industry trends, technology advancement, and contract manufacturing landscape.
Drive risk management, operations excellence, and other Operations initiatives.
Travel 20%: Domestic and International
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic manufacturing professional we seek has the following qualifications:
Doctorate degree and 2 years of Manufacturing or Operations experience
Master’s degree and 6 years of Manufacturing or Operations experience
Bachelor’s degree and 8 years of Manufacturing or Operations experience
Associate’s degree and 10 years of Manufacturing or Operations experience
High school diploma / GED and 12 years of Manufacturing or Operations experience
Bachelor’s in Business Administration, Engineering or Science
8+ years proven experience in protein, Active Pharmaceutical Ingredients, Drug Substance, Drug Product, or packaging manufacturing environment
8+ years working knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
5+ years demonstrated ability working with external parties and/or leading cross-functional teams for clinical and/or commercial products
3+ years of project management experience leading multi-functional and multi-location team
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
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we 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.
for a career that defies imagination
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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.