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.