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Vacancy expired!

Our client is a clinical-stage company focused in the immuno-oncology space. They are seeking a Sr/Principal Engineer, Downstream Process Development and Manufacturing to work hand-in-hand with the Head of Downstream Process Development in the development and manufacturing of both clinical-stage and pre-clinical products. Must have qualifications:

  • 5+ years in industry

  • Extensive hands-on experience with purification process development and/or manufacturing of biologics (AKTA, SEC, IEX, Mixed-mode, AEX, TFF, UF/DF, etc)
  • Experience supporting internal or external technology transfers

  • Strong written and communication skills
A plus if you have:
  • Experience overseeing CDMO partners
  • Experience in with JMP, Minitab, etc for DOE and statistical analysis
  • Oversee process development and manufacturing activities within CDMO partners

  • Review and approve master batch records
    Assist in technology transfers to and between CDMO partners
  • Meet with CDMO partners for PIP, troubleshooting, etc.
  • Assist in the writing of IND and BLA filings
  • Participate in validation, characterization, and DOE activities

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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