Bioengineer-Cell Culture Process Development

Job Locations US-Florham Park
ID
2021-1310
Category
Process Development / CMC
Type
Regular Full-Time

Overview

We are looking for a motivated Bioengineer-Cell Culture Process Development to join our Process Development group to contribute to the development and optimization of cell culture and bioreactor processes for clinical stage cell therapy products. This position requires hands-on execution of process optimization, cell culture media/feeds, and improvements, along with process characterization of cell culture production processes that can be transferred to the manufacturing operations team. Furthermore, this individual is expected to work both independently on assigned tasks/projects and/or collaboratively within a matrix team setting, and provide insight to improve processes and communicate results to the CMC team.

Responsibilities

  • Develops scalable, robust, high yielding, and economically viable cell culture processes using miniature, bench-scale, and larger disposable bioreactors in the process development laboratory setting.
  • Performs hands-on experiments to develop feed strategies and/or optimize medium compositions.
  • Designs and performs experiments to develop the cell culture process, identify key operational parameters, and establish their relationship to quality attributes through Design of Experiments.
  • Perform process scale-up and establish a scale-down model.
  • Executes experiments, analyzes and interprets data to recommend and make process improvements.
  • Collaborates and coordinates material needs with colleagues from other departments
  • Provides investigative support for cGMP manufacturing of pre-clinical and clinical study materials
  • Perform training, draft process descriptions and batch records during tech transfer or regular change control process.
  • Keeps current with advances in upstream processes targeting at further automation and improved yields.

Qualifications

 

  • A minimum of a bachelor’s degree in Biological Sciences, Biotechnology, Chemical Engineering, or other related fields with 5+ years of academic and/or industrial lab experience or a Master degree with 3+ years industrial experience
  • Hands-on experience with mammalian cell culture cultivation/harvest, aseptic techniques, understanding of biochemical engineering concepts, and biochemical pathways.
  • Experience in scale-up and improving scalable upstream processes in PD setting.
  • Excellent record keeping abilities to adequately document process development data.
  • Abilities to formulate experiment protocols and summarize data in report form.
  • Strong verbal and written communication skills.

Preferred Skills

  • Experience with DoE software and application is plus but not necessary.
  • Experience in transferring to MFG and drafting tech transfer documents
  • Experience with wave rocker systems and benchtop bioreactor
  • Experience with close harvest Systems
  • Good understanding on stem cell biology and immunology
  • Familiar with good laboratory practices including equipment maintenance, and the use of analytical tools to acquire in-process data
  • Familiarity with FDA guidance and GMP/quality systems preferred
  • Must be familiar with BSL-II lab safety requirements
  • Occasional weekend work may be required

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