A

Amgen

Makes biotech medicines for serious illnesses

Process Development Associate - Large Molecule Release Testing

Regulatory & Quality (Life Sciences)Updated on Nov 2
Full-timeThousand Oaks, CA, USA

About the Job

Requirements

  • A bachelor's degree, or an associate's degree and 2 years of scientific experience, or a high school diploma/GED and 4 years of scientific experience.
  • Demonstrated ability in the biotechnology industry, including GxP regulations.
  • Experience in cell culture, cell-based bioassay, binding assays, immunoassays, and quantitative polymerase chain reaction (qPCR).
  • Experience developing, qualifying, and testing analytical methods.
  • Ability to work in a fast-paced Good Manufacturing Practice (GMP) environment with strong teamwork.
  • Strong documentation skills and understanding of GxP requirements.
  • Strong oral and written communication skills and attention to detail.

Responsibilities

  • Maintain cell cultures and prepare reagents, media, and buffers, providing related support.
  • Perform routine laboratory maintenance, including restocking, ordering, and assisting with safety actions and audit readiness.
  • Perform cell-based assays, binding assays, enzyme-linked immunosorbent assays (ELISA), and quantitative polymerase chain reaction (qPCR) assays.
  • Generate reliable data, organize and report data in a validated system under minimal direction.
  • Support method hand-off and troubleshooting.
  • Manage critical reagent freezer inventory through detailed manual counts and maintain inventory tracking records.
  • Support release and stability testing of toxicology and clinical batches in a phase-appropriate GMP environment.
  • Support analytical method co-development, co-qualification, and method transfer activities.

Desired Qualifications

  • B.S. or M.S. degree in Cell Biology, Molecular Biology, Biomedical Engineering, Biochemistry, or a related technical subject area.

About the Company

Amgen

Makes biotech medicines for serious illnesses

Amgen develops and makes biologic medicines, which are drugs built from proteins and antibodies grown in living cells, for serious conditions such as heart disease, cancer, and bone loss. Its anemia drug Epogen, approved in 1989, became one of the biotechnology industry's first blockbuster medicines. Amgen grows these drugs in large tanks called bioreactors, and its products include the cholesterol drug Repatha, the bone-building drug Evenity, and the severe asthma drug Tezspire. It earns money by selling these medicines, mostly through large drug wholesalers that supply hospitals and pharmacies. Amgen was founded in 1980 and is based in Thousand Oaks, California.

Company size
10,001+
Company stage
IPO
Headquarters
Thousand Oaks, CA
Founded
1980

Recently Posted Jobs

Explore more opportunities at Amgen

See more jobs