Process Engineer II

Company: bluebird bio
Location: Somerville
Posted on: March 20, 2023

Job Description:

ABOUT THE FLOCK
A Process Engineer II, within the drug substance MSAT team, has advanced engineering knowledge and experience in upstream, downstream, or fill/finish unit operations of biologics, viral vectors or cell culture operations. The scope of the role spans technology transfer to CMOs, authoring regulatory filings, supporting regulatory inspections at CMOs, support technical investigations, and support proactive measures to improve process performance and robustness. You will have accountability for the process performance of unit operations within a GMP setting.
HOW YOU'LL FLY
You'll help to bring more patients their bluebird days by:

• 
  
• Serving as an accountable technical leader for all unit operations at a CMO
  
• Collaborating with Manufacturing and Quality counterparts within bluebird to ensure robust supply of vector supply, autologous cell therapies (Drug substance) and CMO performance
  
• Collaborating with MSAT counterpart at CMOs to deliver timely and correct technical solutions to resolve investigations and to improve manufacturing performance and reliability
  
• Ensuring timely review of process data and developing strategy and execution plan to improve process robustness
  
• Ensuring that standardized root cause analysis and statistical approaches are utilized to support investigations
  
• Staying current on evolving GMP requirements and latest regulatory guidance, supporting regulatory inspections, and writing and reviewing sections of regulatory filings
  
• Supporting technology transfers and process validation of upstream, downstream, or fill/finish unit operations
  
• Interfacing with process monitoring (i.e., CPV) team to review trends and takes proactive measures to improve process robustness and quality
  
• Supporting complex investigations to ensure timely resolution and delivering robust technical package to support lot disposition
  
  WHAT YOU'LL BRING
  You're the bird we're looking for if you have:
  
  • 
    
  • B.S. or M.S. in a scientific or engineering discipline and 2-5 years of experience, or Ph.D. with 1+ years of experience
    
  • Prior experience in cell and gene therapy or biologics and vaccines
    
  • Prior experience supporting investigations, technology transfer, process monitoring, process validation, and routine clinical/commercial support in a GMP setting
    
  • Expertise in cell culture or purification technologies and emerging breadth in understanding cell culture to fill/finish operations
    
  • Experience in regulatory inspections of manufacturing facilities and knowledge of regulatory filings
    
  • Understanding of QbD approaches
    
  • Track record of creative approaches to problem solving and improving efficiency of MSAT workflows
    
  • Preferred experience in technology transfer to CMOs
    
    Hybrid preference for this role however remote candidates will be considered
    

Keywords: bluebird bio, Somerville , Process Engineer II, Engineering , Somerville, Massachusetts