Bioengineer

Job Locations US-NJ-Florham Park
ID
2021-1720
Category
Process Development / CMC
Type
Regular Full-Time

Overview

Celularity is a next-generation Biotechnology company creating off-the-shelf cellular medicines for Cancer, Infectious Diseases, and Degenerative Diseases.  Our employees are experienced cellular medicine leaders and innovators and are revolutionizing the way the industry approaches disease.

 

We are looking for a motivated Bioengineer 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 and cell culture media/feeds, along with process characterization of cell culture production processes that must be transferred to the manufacturing operations team. Furthermore, this individual is expected to work independently on assigned tasks/projects and provide insight to improve processes and communicate results to the CMC team. Ideal candidates will have demonstrated process development experience in cell therapy and/or biologics and will be detail-oriented with excellent organization, documentation, and communication skills.

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 using chemically defined medium.
  • Executes experiments, analyzes, and interprets data to recommend and make process improvements.
  • Executes process monitoring and control strategies for robust process design.
  • Collaborates and coordinates material needs with colleagues from other departments.
  • Provides investigative support for cGMP manufacturing of pre-clinical and clinical study materials.
  • Reviews 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 3+ years of academic and/or industrial lab experience.
  • Excellent record keeping abilities to adequately document process development data.
  • Detail-oriented and able to prioritize assignments.
  • Strong verbal and written communication skills.
  • Ability to maintain an electronic lab notebook.

Preferred Skills

  • Must have previous hands-on experience with mammalian cell culture, aseptic techniques, understanding of biochemical engineering concepts, and biochemical pathways.
  • Must have experience in developing and improving scalable upstream processes in Process Development setting.
  • Must have demonstrated proficiency to use Design of Experiments in JMP, Design Expert, or other for statistical experimental design, and data analysis.
  • Must be familiar with good laboratory practices including equipment maintenance, and the use of biochemical analytical tools to acquire in-process data.
  • Must have proactive maintenance of laboratory space.
  • Must have familiarity with FDA guidance and quality systems.
  • Preferred experience preferred in transferring to MFG.
  • Preferred experience with GE Xuri /wave rocker systems (CHemglass, biostat RM…etc) and benchtop bioreactor.

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