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Amgen

Makes biotech medicines for serious illnesses

Associate Manufacturing

Bioprocess & BiomanufacturingPosted on Nov 13
Full-timeThousand Oaks, CA, USAIn-person

About the Job

Requirements

  • A bachelor's degree, or an associate's degree plus six months of manufacturing and/or operations work experience, or a high school diploma/GED plus two years of manufacturing and/or operations work experience.
  • Ability to perform computer operations, including navigating Microsoft Office and Excel.
  • Ability to operate specialized equipment and computers appropriate to the assigned area.
  • Ability to adhere to regulatory requirements, written procedures, and safety guidelines.
  • Ability to evaluate documentation and data according to company and regulatory guidelines.
  • Ability to interact with internal and external inspectors.
  • Technical writing capabilities.
  • Ability to organize work, handle multiple priorities, and meet deadlines.
  • Demonstrated written and oral communication skills.
  • Presentation capabilities.
  • Detail orientation, flexibility, and adaptability to changing priorities and requirements.

Responsibilities

  • Collaborate routinely with multiple functions at the Thousand Oaks site, including Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, and Process Engineering, while developing an understanding of manufacturing operations and facility planning activities.
  • Execute drug product filling activities.
  • Perform initial reviews of manufacturing batch records.
  • Maintain a safe and compliant culture by identifying preventative measures.
  • Create and/or revise standard operating procedures.
  • Lead continuous improvement initiatives, which may be cross-functional.
  • Perform data analysis, such as statistical process control and continued process verification, of critical process parameters and make recommendations to Engineering and/or Process Development teams.
  • Develop finite schedules for tasks, including unit operations.
  • Monitor productivity and identify countermeasures for issues affecting cycle-time adherence.
  • Elevate critical and impactful events to management.
  • Apply appropriate systems for job duties, including SAP, QMTS, and LIMS.
  • Support the introduction of new products and technologies into the facility.
  • Initiate and own quality records, including non-conformances and corrective/preventative actions.

Desired Qualifications

  • A Bachelor of Science degree in a life science or related field.
  • Two years of work experience in a Good Manufacturing Practice environment.

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

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