Amgen Manager Quality Control in Thousand Oaks, California

Primary focus is providing analytical support to for the HPLC and CE groups within ATO QC. Key responsibilities include:

  • Supervise a workgroup of 5-10 analysts

  • Manage a variety of tasks to timelines based on priorities

  • Ensure compliance with procedures relating to area of responsibilities

  • Proactively assess processes for continuous improvement opportunities

  • Approve QC records

  • Partner with key Manufacturing clients to ensure needed support from QC

  • Own GMP materials relating to area of responsibility

  • Support investigations relating to area of responsibility

  • Participate in regulatory inspections and site audits.

  • Present information relating to workgroup activities

  • Knowledge of relevant analytical technologies including HPLC, UHPLC and Capillary Electrophoresis and Chromatography Data Systems (CDS).

Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of Quality, Manufacturing or Operations experience

OR

Bachelor's degree and 5 years of Quality, Manufacturing or Operations experience

OR

Associate's degree and 10 years of Quality, Manufacturing or Operations experience

OR

High school diploma / GED and 12 years of Quality Manufacturing or Operations experience

And

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications :

  • BA-BS/MS in Chemistry or other Life Science field.

  • 2-3 years previous experience as a laboratory/staff manager

  • In depth knowledge of relevant Chromatography tests such as Size Exclusion, Reversed Phase, and Ion Exchange techniques using HPLC and UHPLC instruments. In addition, an understanding of Capillary Electrophoresis (CE) and SDS-PAGE and cIEF gel techniques.

  • General knowledge of chromatography and CE equipment, and maintenance and repair of

  • Able to facilitate and influence clients and partners

  • Able to successfully manage workload and staff to timelines

  • Able to apply Operational Excellence to activities both real time and strategically

  • Experience managing a large workgroup

  • Experience in commercial and clinical manufacturing

  • Familiarity with (or ability to learn) Power Point, VISIO, EDMQ and NC/CAPA systems

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.

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.