Career CategoryProcess DevelopmentJob Description
Amgen seeks a Manager for its External Process Development team. The successful candidate can work at Amgen's corporate headquarters in Thousand Oaks, CA or at its site in Cambridge, MA.
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 Manager External Process Development will work with Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) utilizing a strong understanding of drug development, commercialization, and business management. The successful candidate will lead the implementation of sourcing initiatives and will manage a variety of external projects engaging domestic, international, and emerging market suppliers.
To deliver successfully, the Manager will 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
This position will require occasional domestic and international travel (approximately 10% total)
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 current Good Manufacturing Practices (cGMP), Regulatory/Chemistry,
Manufacturing and Controls (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
Amgen is committed to unlocking the potential for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.