Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.
Advancing science and helping patients - these dual passions are ingrained in our culture. They drive our work, our values, and everything we do at Amgen. For staff around the world, our mission to serve patients and our commitment to science makes Amgen a place where we can make a positive difference in people's lives while pursuing a challenging and fulfilling career. To foster a setting in which all staff may excel, we support a variety of growth opportunitiesfrom training and education to expanding current job responsibilities.
Amgen is searching for a Manager of External Process Development. This role can be based on either our main corporate campus in Thousand Oaks, CA or in our Cambridge, MA office, with the preference being Cambridge, MA. This will report to our Research Operations Senior Manager.
Process Development (PD) is responsible for enabling commercialization of the product pipeline, product lifecycle management, and technical manufacturing support of Amgen commercial products. The External Process Development group (XPD) was created to develop PD's sourcing strategy and drive the implementation across the development portfolio. External Process Development is part of the newly formed Business Analysis and Performance group which is responsible for business analysis, development sourcing strategy and execution, resource and budget planning, and performance management for PD.
The External Process Development Manager will work with CRO/CMO's while driving drug development, commercialization, and business management. This Manager will lead the implementation of sourcing initiatives and will manage a variety of external projects engaging domestic, international, and emerging market suppliers. The Manager will successfully, establish a strong partnership across all PD functions and with key business partners.
The responsibilities of this role include:
Project leadership for a portfolio of cross-disciplinary external projects traversing the areas of large and small molecule Drug Substance, Drug Product, and Attribute Science
Identification of project opportunities, prioritization, and maintenance of rolling portfolio
Ensuring programs meet compliance, speed, quality, and cost targets
Working under minimal direction, management of multiple assignments and business processes
Building and maintaining of strong partnerships with all Process Development functions to increase overall effectiveness and success of programs
Supplier evaluation and selection
Supplier relationship management, including development and reporting of metrics and monitoring performance to continuously improve efficiency and effectiveness of suppliers
Creation of holistic business cases considering strategic, financial, and risk tradeoffs
Presentation of analyses and recommendations to Senior Management
Occasional domestic and international travel
Master's degree and 3 years of Scientific experience
Bachelor's degree and 5 years of Scientific experience
Associate's degree and 10 years of Scientific experience
High school diploma / GED and 12 years of Scientific experience
Advanced degree in engineering or science
Self-starter with a high-level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results
Experience interfacing with CMO/CRO organizations
Strong understanding of cGMP, Regulatory/CMC, legal, and import/export policies
Demonstrated understanding of drug development and commercialization for large and/or small molecule therapeutics
Experience as team member/leader of cross-functional and matrixed teams including effective writing, presentation, and interpersonal skills to address a broad scope of audiences
Proven business acumen, high level strategic thinking, and strong analytical skills with the ability to structure, pragmatically scope, and solve complex problems
Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence and performance management
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.