Process Engineer - Fujifilm

This role focuses on the automation and scale-up of bioprocesses for manufacturing products from pluripotent stem cells to include but not limited to immunotherapy, CAR-T, and NK cells.  The process engineer will provide technical expertise in cGMP cell manufacturing including bioreactors, cell washing and concentration technologies, and fill/finish operations.

Essential Job Functions

1. Evaluate and implement technology to improve consistency, increase scale, and improve cGMP compliance of bioprocesses for manufacturing iPSC-derived therapeutics.
2. Develop scale-down models for process optimization studies.
   
   
3. Designs, executes and evalutes process analytic technologies (PAT) for improved monitoring and control of stem cell bioprocesses.
4. Write protocols, technical reports, and Standard Operating Procedures (SOPs).
   
   
5. Designs and executes laboratory experiments independently
   
   
6. Supports and occasionally leads the development and documenting of standard methods for cell processing unit operations including bioreactor-based cell culture, media manufacturing, cell washing and concentration

1. Prepares experimental protocols, technical reports, and SOP's, and develops appropriate documentation for the process development and tech transfer of processes to DR and TX manufacturing.
2. Supports investigations and occasionally leads continuous improvement projects related to materials, equipment, and processes.
3. Effectively communicates information about the projects and experimental results within the project team, to other FCDI groups and occasionally to senior management, external customers and clients.
   
   
4. Other job functions as assigned.

Qualifications

• D. in Bioengineering, Chemical Engineering, or Biological Sciences, or Master’s degree in a comparable field plus two to five years of relevant experience, or a Bachelor’s degree with five or more years of experience
• Up to two years of postgraduate experience, with demonstrated achievements and progressive responsibilities
• Demonstrated proficiency with mammalian cell culture processes - preferably bioreactors
• Strong organizational, troubleshooting and interpersonal skills along with excellent oral and written communication
• Demonstrated ability to work in a fast-paced, collaborative, and matrixed organization environment.
• Ability to work a flexible schedule as weekend work is required
• Relevant experience or understanding of the following:
  • Process development as a member of product/process development teams.
  • cGMP biomanufacturing
  • Pluripotent stem cells and/or differentiation.
  • Immunobiology, immunotherapy, and related manufacturing techniques.
  • Various cell and molecular techniques including flow cytometry, Q-RT-PCR, fluorescence microscopy, and high content imaging.