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Process Development Engineer/Associate

TYPE: Full-Time
LOCATION: San Diego, CA USA

Overview

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

Job Description

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

Apply for this position