Amgen Sr. Manager Process Development in Thousand Oaks, California
The External Process Development (XPD) organization is seeking a highly qualified candidate to lead early stage Drug Product outsourcing strategy and capability expansion within Amgen’s Process Development function. The Senior Manager will be responsible for overseeing a wide portfolio of drug product outsourcing projects delivering developmental data, toxicology and early clinical material. Across a range of biologics and synthetic programs, the role will develop an outsourcing strategy in the drug product space with clients, establish key partnership with vendors, execute projects both developmental and routine in nature to advance Amgen’s commercialization pipeline. The role will also engage in analytical aspects and strategic aspects of externalization.
Develop and execute XPD drug product outsourcing strategy with internal clients
Oversee execution of XPD drug product projects at multiple vendors
Establish and maintain external collaborations, develop SOWs, manage purchase orders and associated budget for externalization activities
Develop KPIs regarding performance metrics with vendors
Identify and establish needed capabilities regarding drug product execution and development
Support biologics and synthetic outsourcing programs
Travel as required
The External Process Development group (XPD) develops PD’s sourcing strategy and drives the implementation across the development portfolio. External Process Development is part of the Business Analysis External Process Development organization (BAX) which is responsible for business analysis, development sourcing strategy and execution, resource and budget planning, and performance management for PD.
Doctorate degree and 2 years of engineering, science or business management experience
Master’s degree and 6 years of years engineering, science or business management experience
Bachelor’s degree and 8 years of engineering, science or business management experience
Associate’s degree and 10 years of years engineering, science or business management experience
High school diploma / GED and 12 years of engineering, science or business management experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Strong drug product development and analytical background
Strong understanding of cGMP, Regulatory/CMC, legal, Quality requirements and import/export policies
Demonstrated understanding of drug development and commercialization for synthetic and biologic therapeutics
Experience as team member/leader of cross-functional and matrixed teams including effective writing, presentation, organizational and interpersonal skills to address a broad scope of audiences
Strong quantitative and qualitative skills including financial analysis, cost accounting, and product lifecycle management
Demonstrated understanding of pharmaceutical/bio-pharmaceutical manufacturing
Strong writing and presentation skills
Strong interpersonal and influencing skills with a demonstrated ability to drive decisions
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 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.