Associate Manufacturing

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 Manufacturing Associate position is part of the Amgen, Thousand Oaks, Drug Product Supply organization. This is a manufacturing support role responsible for manual visual inspection and testing in manufacturing operations teams. This Associate position will be focused on:
  • Characterization, sample, data, and equipment management
  • Process improvement projects/assignments within operations
  • Quality systems (LIMS/MES/SAP/MAXIMO) support
  • Support new product introduction activities
  • Support production
  • Maintain open communication between operations teams

This Associate position will be focused on manual visual inspection and testing in manufacturing operations.

Job Scope and Responsibilities:
  • Under minimal supervision, performs manufacturing and laboratory unit operations according to Standard Operating Procedures
  • May schedule operations for multiple functional areas
  • Understand process parameters and can identify process anomalies
  • Operate critical processing equipment
  • Assist and implement continuous improvement solutions related to routine functions
  • Assist in ensuring operations are completed per manufacturing schedule
  • Resource related to processing operations on the mfg. floor/laboratory
  • Identify and propose solutions to complex problems
  • Responsible for identifying and communicating problems during operations
  • Perform initial review of manufacturing/laboratory procedures/batch records
  • Review, revise, and audit documents
  • Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)
  • Provide hands-on training to others
  • Provide suggestions/ideas for corrective actions and preventative actions for deviations/safety incidents
  • Applies research, information gathering, analytical and interpretation skills to problems of diverse scope
  • Utilizes basic project management skills to set project timelines and priorities based project objectives and ongoing assignments
  • Recognizes and escalates problems
  • Able to establish working relationships with others outside area of expertise
  • Ability and willingness to support flexible shift structure in support of operations (may include 24/7 or weekend)
  • Ability to understand, apply, and evaluate basic chemistry, biology, and physical principals as appropriate for the position
  • Organizational skills and an ability to perform assignments with a high degree of attention to detail
  • Written and oral communication skills. Technical writing capability
  • GMP knowledge with ability to interpret and apply applicable regulations
  • Ability to understand analytical methods for manufacturing/laboratory area

Basic Qualifications:

Master's degree

Or

Bachelor's degree and 1 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)

Or

Associate degree and 3 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)

Or

High School Diploma/GED and 6 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)

And

Prior experience with lab equipment, computers, and intermediate mathematical skills

Preferred Qualifications:
  • Experience with manual visual inspection and/or laboratory in a GMP regulated environment.
  • Experience with PAS X Werum software for electronic batch records with some understanding of editing and validation
  • Degree in Engineering, Chemistry, Biochemistry, Biology or Computer Science with experience in biotechnology
  • Demonstrated technical writing capability
  • Knowledgeable of manual visual inspection and laboratory background or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)
  • Demonstrated ability to work in a team


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.