27 days old

Process Development Associate

Amgen
Cambridge, MA 02138
  • Job Code
    119978236
Amgen

Job ID: R-98735
Location: Cambridge, MA, US 02139

Amgen is seeking a Process Development Associate to join our team and work from Amgen's beautiful Cambridge, MA, campus. This position is responsible for developing, qualifying, transferring and performing state-of-the-art and fit-for-purpose quantitative assays for the measurement of DNA, proteins and other biological analytes in support of manufacturing process development.

Responsibilities include:
  • Developing, implementing and performing state-of-the-art and fit-for-purpose analytical methods for: impurity characterization and release testing.
  • Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions
  • Generating, documenting, analyzing, and interpreting analytical data to support: product development investigations, and regulatory submissions
  • May participate or contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation
  • Keeps current in analytical development field including literature and technology development for cutting edge and regulatory driven activities
  • Supporting analytical projects involving method development, qualification, and transfer
  • Provides critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), investigations and regulatory submissions


Basic Qualifications:

Bachelor's degree

OR

Associate's degree and 4 years of scientific experience

OR

High school diploma / GED and 6 years of Scientific experience

Preferred Qualifications:
  • Experience and expertise with protein assays, particularly ELISA as well as most common formats for measuring protein-protein interactions.
  • Experience with protein gel electrophoresis and western blotting techniques.
  • Experience and expertise with molecular biology, particularly qPCR and DNA isolation.
  • Experience with automation platforms, specifically large-scale liquid handlers
  • Experience and expertise with the use of electronic notebooks, as well as Microsoft Office software, particularly Word, PowerPoint and Excel
  • Experience working in a GMP regulated environment, as well as with regulatory filings (IND, BLA, and NDA) and ICH Guidelines
  • Innovation - positive approach to challenges; champions new ideas and initiatives; brings out and utilizes others' creativity to improve unit performance
  • Client orientation- establishes effective and responsive relationships with all clients; translates client requirements into work design; ensure value is delivered
  • Communication - establishes and maintains effective communication mechanisms to keep staff appropriately informed; bridges communication between individuals, units and other organizations as necessary
  • Interpersonal skills - communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood


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.



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Posted: 2020-04-29 Expires: 2020-05-30

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Process Development Associate

Amgen
Cambridge, MA 02138

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