Manufacturing Engineer II

This role will focus on hands-on process development, process characterization, technology transfer, and implementation of new technologies for clinical and commercial manufacturing. The successful candidate will work cross-functionally with Research, Development, Manufacturing, Quality, and Engineering teams to develop robust, scalable, and GMP-compliant cell therapy processes.

Key Responsibilities

• Design and execute hands-on laboratory experiments for cell therapy process development, characterization, and optimization using automated platforms.
  
• Develop and evaluate cell culture processes, materials, technologies, and equipment for introduction into GMP manufacturing.
  
• Perform cell culture and aseptic processing activities in an ISO 5 environment, including cell passaging, sampling, fluid handling, media preparation, reagent management, and cryopreservation.
  
• Analyze and trend process and equipment performance; identify opportunities for process improvements and troubleshoot technical issues.
  
• Support development and implementation of cell therapy manufacturing equipment, including hardware, software, single-use systems, and user requirements.
  
• Support technology transfer, scale-up/scale-out, process implementation, and GMP manufacturing operations.
  
• Apply Design of Experiments (DOE) and statistical analysis using JMP, Minitab, or similar tools.
  
• Prepare and review protocols, SOPs, manufacturing batch records, technical reports, and regulatory-supporting documentation.
  

Required Qualifications & Experience

• MS with 2+ years, BS with 4+ years, AS with 5+ years, or equivalent experience in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or a related discipline.
  
• Experience in pharmaceutical/biotechnology manufacturing and process development.
  
• Hands-on experience with automated cell therapy platforms.
  
• Strong cell culture and aseptic processing experience in an ISO 5 environment.
  
• Practical knowledge of cGMP manufacturing and pharmaceutical/medical-device regulatory requirements.
  
• Hands-on process development experience with bioreactors, process monitoring, and DOE/statistical analysis.
  
• Understanding of bioprocess engineering principles including scale-up/scale-out, hydrodynamics, mass transfer, and bioreactor design
  

Preferred Qualifications

• Flow cytometry experience.
  
• mRNA handling and process development experience.
  
• Experience with automated cell therapy manufacturing platforms.
  
• Experience supporting technology transfer into GMP manufacturing.
  
• Experience with JMP, Minitab, or other statistical/process modeling tools.