Job Description

Responsibilities:

  • Provide technical and on-floor support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products. This includes troubleshooting, participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events.
  • Act as the Process Teams product and process subject matter expert for purification processes which may include chromatography, tangential flow filtration, and centrifugation.
  • Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements.
  • Develop / execute projects to address process performance issues and deliver improvement opportunities.
  • Author and provide critical review of technical documents including, but not limited to; batch records, SOPs, PFDs, p...

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