Manager Quality Control

The Quality Control Manager will be responsible for supervision of all technical and operational activities within the QC Bioassay Laboratory at Amgen, Thousand Oaks.

Responsibilities:

• Oversees the execution of testing including routine analysis, cell bank Stability and testing in support of technology transfer for analytical methodologies
• Provides Bioassay technical expertise/guidance to lab staff and within cross-functional Amgen teams
• Manages the Bioassay Lab daily operations in relation to planning and management of materials, critical reagents, equipment and laboratory staff
• Owns and reviews controlled documents, including Standard Operating Procedures, Analytical Methods, Protocols and Reports related to Bioassay Lab activities
• Ensures that the Bioassay Lab operations comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety and Laboratory Controls.
• Represents the Bioassay Lab during Amgen internal/external audits and inspections. Direct interaction with regulatory agencies during on-site inspections.
• Provides oversight of Bioassay Lab Quality Systems records including Deviations, CAPAs and Change Controls
• Selects, develops and evaluates laboratory staff to ensure functional objectives are met

Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Bioassay experience

OR

Bachelor's degree and 5 years of Bioassay experience

OR

Associate's degree and 10 years of Bioassay experience

OR

High school diploma / GED and 12 years of Bioassay experience

AND

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

Preferred Qualifications

• Advanced Degree in Scientific Discipline
• Strong knowledge in Bioassay Laboratory techniques
• Familiarity with the technology transfer process. Experience with validating analytical methods and ensuring that project deliverables meet established timelines.
• Strong level of analysis skills to evaluate and interpret data to arrive at logical and quality-minded conclusions. Experience applying problem-solving tools for root cause analysis.
• Proven leadership capabilities and experience applying GMP requirements in a Quality Control setting
• Demonstrated ability to develop, coach and mentor employees
• Excellent interpersonal, verbal and written communication skills with all levels within the organization
• Experience with successfully managing a team and delivering results in fast-paced and dynamic work environment

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.