Senior Upstream Process Development Scientist

Cambridge, MA | Contract

Post Date: 05/10/2018 Job ID: 226341 Industry: Life Sciences

Senior Upstream Process Development Scientist

Job Description:
  • Develop stable cell lines for antibodies, antibody-like, fusion
  • Develop CHO cell culture production processes, including clone selection, media optimization, and defining bioreactor process parameters
  • Coordinate scale-up and technology transfer activities to support early stage cGMP manufacturing
  • Lead characterization activities for the manufactured cell lines, including stability and safety
  • Provide technical documentation in support of filings with regulatory agencies
  • Independently design and execute complex experiments and projects
  • Support downstream process development and analytical development efforts
Primary Qualifications:
  • BS/MS/PhD in Science or Engineering with at least 5-10 years of relevant experience in
  • the biopharmaceutical industry
  • Hands on experience in stable cell line generation using mammalian systems
  • Hands on experience with lab scale cell culture bioreactors and shake flasks
  • Proven track record of improving expression and/or quality of recombinant protein production processes
  • Familiarity with cGMPs for biopharmaceuticals and regulatory submissions 
  • Lead or participated in tech transfer to/ from a CMO for cGMP operations
  • Experience designing downstream processes
  • Performed analytical method development

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