20 days old

Senior Associate Manufacturing - MES Designer

Woburn, MA 01801
  • Job Code

Job ID: R-100743
Location: Woburn, MA, US 01806

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.

As part of the Amgen's Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in detailed execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement attitude, and an unyielding focus on safety, quality, and compliance.

This role of Senior Associate Manufacturing for AWM reports directly to the Manager of Manufacturing. Under minimal supervision; the Sr. Associate will perform operations for drug substance and drug product operations according to Standard Operating Procedures (SOPs).

Shift: Monday - Friday Admin Day Shift

Responsibilities include, but are not limited to the following:

  • Provides technical leadership to the team under the direction of the Front-Line Manager
  • Create and maintain Electronic Batch Records.
  • Drive continuous improvements of MBR System and PLM processes.
  • Partner with manufacturing staff to develop and/or revise manufacturing SOPs to support manufacturing processes including buffer, cell culture, purification, filling, inspection and freezing.
  • Develop and maintain the Bill of Materials for each product/process manufactured at AWM.
  • Support the development of manufacturing sample plans.
  • Develop and maintain User Requirements (URS) for manufacturing equipment.
  • Assist in developing and delivering training materials to manufacturing staff.
  • Own and manage change controls, deviations, and CAPAs
  • Participates on cross-functional teams across the site
  • May also have the responsibility of owning NC and CAPA's
  • Identifies, recommends, and implements improvements related to routine functions

Basic Qualifications:

  • Master's degree
  • OR
  • Bachelor's degree and 2 years of Manufacturing and/or Operations experience
  • OR
  • Associates degree and 6 years of Manufacturing and/or Operations experience
  • OR
  • High school diploma / GED and 8 years of Manufacturing and/or Operations experience

Preferred Qualifications:

  • Strong understanding of biomanufacturing equipment and processes
  • Experience with SAP and MES
  • Mechanical ability/expertise
  • Basic statistical mathematical skills
  • Ability to interpret and apply GMP knowledge
  • Understanding of analytical methods for the manufacturing area
  • Ability to demonstrate technical writing capability
  • Able to demonstrate project management skills and presentation skills
  • Independently collaborate with outside resources
  • Ability to understand, apply and evaluate basic chemistry, biology and physical principles
  • Strong analytical and experimental design skills
  • Strong troubleshooting and problem-solving skills
  • Experience with automation systems
  • Experience with Lean Manufacturing Principles

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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.



Posted: 2020-07-14 Expires: 2020-08-14

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Senior Associate Manufacturing - MES Designer

Woburn, MA 01801

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