Sr. Process Engineer

Our large Gene Therapy client here in Cambridge, MA is growing and looking to add a Sr. Process Engineer to their team!  This role will support the development of closed and automated clinical scale manufacturing processes and provide supervision, training and guidance to direct report(s).  Other responsibilities include but not limited to:

  • Author and review process-related documentation (SOPs, batch records, study protocols, technical reports) to support development and GMP manufacturing
  • Design and execute studies to evaluate, optimize and troubleshoot systems and processes for cell processing
  • Compile, analyze, and present process data at functional team meetings
  • Document all experimental work in the electronic lab notebook (ELN) in a timely manner
  • Work with Analytical Development team to generate data to develop understanding of most relevant critical quality attributes of cellular products to guide safe and effective clinical testing
  • Draft change controls, deviations, CAPAs, support root cause analysis and OOS investigations as needed
  • Support technology transfer of cellular manufacturing process to internal manufacturing team as well as external CDMO partners

 

Requirements

  • PhD in Chemical Engineering, Biomedical Engineering or related technical/scientific field with 2-5 years of process development experience; or
  • Master’s with 8+ years process development experience.
  • Experience developing and commercializing cell therapy products
  • Experience with automated cell processing systems and closed processes
  • Strong problem-solving skills, self-motivated with ability to work under pressure to meet deadlines
  • Attention to detail and the ability to work individually, within a multi-disciplinary team in a matrix environment, as well as with external partners and vendors
  • Experience with technology transfer or process validation is a plus