19 days old

Process Development Associate

Cambridge, MA 02138
  • Job Code

Job ID: R-99205
Location: Cambridge, MA, US 02139

Amgen is a biopharmaceutical leader founded on discovering, developing, manufacturing, and delivering innovative human therapeutics. Amgen's Commercial Attribute Sciences group within Process Development is seeking a Process Development Associate. The Process Development Associate will be responsible for the authoring and analysis of method transfer and method validation protocols and reports. This candidate will help to deliver on Amgen's full portfolio of method implementations by executing against method validation/transfer processes and effectively communicating with internal and external partners across a global network.

The Process Development Associate role in Commercial Process Development will be part of a team (Global Method Implementation Team) responsible for authoring method transfer and method validation protocols and reports for clinical through commercial programs. Method types will include all modalities and at a minimum the following method platform: Chromatography, Bioassay, PCR, Immunoassay, CE/Gel, Viral, Mass Spectrometry, Spectroscopy, and General/compendia. Protocols and reports will be authored according to regulatory and industry guidelines (i.e., ICH/etc.). This individual will support clinical and commercial locations throughout the company. This position works closely with representatives from key functions within Process Development, Manufacturing and Quality.

Basic Qualifications:

Bachelor's degree


Associate's degree and 4 years scientific experience


High school diploma and 6 years scientific experience

Preferred Qualifications:

Bachelor's degree in Chemical Engineering, Biochemical Engineering, Life Sciences, or other relevant sciences

Understanding and hands-on experience in various method types (e.g., Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, Device, Viral, and Compendia)

Understanding and authoring experience with method transfer and method validation protocols and reports with direct experience at a Pharmaceutical or Biotechnology company

Knowledge of analytical methods/technologies used in biologic and/or synthetic development and manufacturing

Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment

Demonstrated ability to critically analyze and interrogate various analytical data sets to drive and influence the process

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: 2020-05-07 Expires: 2020-06-07

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Process Development Associate

Cambridge, MA 02138

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