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Sr. Manager Process Development

Employer
Amgen
Location
Thousand Oaks, CA, US
Start date
Aug 9, 2019

Job Details

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.

Job Responsibilities:
  • 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.

Basic Qualifications

Doctorate degree and 2 years of engineering, science or business management experience
OR
Master's degree and 6 years of years engineering, science or business management experience
OR
Bachelor's degree and 8 years of engineering, science or business management experience
OR
Associate's degree and 10 years of years engineering, science or business management experience
OR
High school diploma / GED and 12 years of engineering, science or business management experience

Preferred Qualifications
  • 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.

Join Us

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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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