The Amgen External Process Development (XPD) organization is seeking a high qualified Manager Process Development to join the synthetic drug substance outsourcing team. This role can be based on either our main corporate campus in Thousand Oaks, CA or in our Cambridge, MA office and will report to our Process Development Senior Manager managing the synthetics drug substance outsourcing team.
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 of this strategy across the development portfolio.
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:
• Technical project leadership for cross-disciplinary external projects traversing the areas of Drug Substance, Drug Product, and Attribute Sciences with a focus on the late stage synthetics drug substance portfolio
• Work under minimal direction to manage of multiple assignments and/or business processes
• Build and maintain strong partnerships with all Process Development functions to increase overall effectiveness and success of programs
• Supplier evaluation and selection
• Establish and maintain external collaborations, develop scopes of work, manage purchase orders, and associated budget for externalization activities
• Monitor performance to continuously improve efficiency and effectiveness of suppliers
• Manage spend and adhere to financial targets and systems
• Ensure programs meet compliance, speed, quality, and cost
• Present analyses and recommendations to Senior Management
• Occasional domestic and international travel to support project deliverables
Master's degree and 3 years of Scientific experience
Bachelor's degree and 5 years of Scientific experience
OR Associate's degree & 10 years of Scientific experience
OR High school diploma/GED & 12 years of Scientific experience
• Advanced degree in engineering or science
• Demonstrated understanding of drug development and commercialization for small molecule therapeutics, including route scouting, raw material and starting material procurement, API manufacture, process development, process engineering and process characterization
• 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 domestic and international CMOs/CROs
• Strong understanding of cGMP, Regulatory/CMC, legal, Quality requirements, and import/export policies
• Experience as team member 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 of biology 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.
Amgen's outstanding compensation package features comprehensive benefits. To learn more about this opportunity and to apply, please visit us online at http://careers.amgen.com/ and search job #R-92909.
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.