Process Development Engineer/Associate

Job Type: Full Time
Job Location: San Diego

This is an intermediate experienced engineer/associate position that will play an important role in developing robust cell culture processes to be used in clinical manufacturing. This person will also play a key role in transition MabPlex’s PD/MFG build-out in San Diego. Experience will dictate the exact title.

The position will report to the Associate Director of Upstream Process Development.

Essential Job Responsibilities:

  • Engage with business development for new client projects
    • Meet with prospective clients to understand needs
    • Propose solutions for client needs
  • Lead development of robust cell culture processes for clients
    • Shake flask fed-batch studies to develop optimal basal/feed media
      • OFAT/DOE screening as necessary
    • Bioreactor process optimization
    • Scale-up process optimization (up to 200 L scale)
    • Tox lot production
    • Deliver presentations to clients
    • Author development reports
  • Technology transfer of processes to manufacturing site
    • Author technology transfer report and process description
    • Review batch records for completeness
    • Perform person-in-plant (PIP) activities
  • Lead development and implementation of new technologies
    • Develop an automated process with AMBR 250 system
    • Investigate perfusion/process intensification
      • Develop tools to aid automation and controls
    • Assist with cell line development activities
      • Transfection for stable and transient cell lines
      • Screen minipools and create clonal cell lines
      • Shake flask fed-batch studies to support stability and top clone selection

Qualifications:

  • BS in a related science or engineering discipline with a minimum of 5 years’ experience or MS with a minimum of 3 years’ relevant experience
  • Proficient in cell culture and aseptic techniques
  • Good problem solving, organization and collaborative skills are essential
  • Must be accountable and possess good communication skills (verbal and written)
  • Strong understanding of bioreactor control systems
  • Experience with pilot-scale SUBs preferred
  • Solid understanding of DOE models

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