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Amgen Senior Associate Manufacturing - NPI/EBR in Thousand Oaks, California

Job Summary

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.

The New Product Introduction/Electronic Batch Record (NPI/EBR) Senior Associate position is part of the Amgen, Thousand Oaks, Drug Substance Supply organization. This is a manufacturing support role responsible for the generation of electronic documentation, for tracking of NPI/EBR metrics and for communication between the Good Manufacturing Practice operations teams and the process development scientific groups. This Senior Associate position will be focused on downstream purification operations.

Job scope and responsibilities:

  • Manufacturing support focused on Electronic Batch Record (EBR) generation, editing, order network initiation and managing the EBR validation for new or modified processes.

  • Assisting in the implementation of equipment management.

  • Generation of paper process documents when required.

  • Leading resupply process execution efforts including coordinating with Supply Chain, Planning, Facilities and Automation Engineering as well as Manufacturing to ensure that production documents (paper and electronic) are accurate and up to date.

  • Contributing to Lean Transformation through recording NPI metrics and application of continuous improvement tools.

  • Participate and contributing to projects to introducing new products and/or advanced cell culture technologies into the plant.

Basic Qualifications:

Master’s degree

OR

Bachelor’s degree and 2 years of Manufacturing or Operations experience

OR

Associate’s degree and 6 years of Manufacturing or Operations experience

OR

High school diploma / GED and 8 years of Manufacturing or Operations experience

Preferred Qualifications :

  • Significant experience with purification process scale operations in a GMP regulated environment (chromatography, viral inactivation, viral filtration, UF/DF, buffer prep)

  • Significant experience with PAS X, Werum software for electronic batch records with some understanding of editing and validation

  • Degree in Chemical Engineering, Biochemistry, Chemistry or Biology or Computer Science with experience in biotechnology

  • Demonstrated technical writing skills

  • Strong operations knowledge of purification and a broad understanding of related disciplinary areas in bioprocessing (cell culture, harvest, Drug Product operations)

  • Demonstrated ability to work in a team

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.​

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