Process Development Engineer/Associate (experience will dictate exact title)

Purpose & Scope: 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 to transition MabPlex’s PD/MFG build out in San Diego.

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 perspective 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 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