Sr. Manager, Process Development

Our Gene Therapy client in Cambridge, MA is growing and looking to add a Sr. Manager, Process Development to their team!  This role will manage a team and oversee collaborating teams with Research into Process Development.  Other responsibilities included but not limited to:

  • Performing process development and optimization.
  • Manage collaboration with AD to generate data to support formulation studies, stability studies, and characterization of drug substance and/or drug product.
  • Ensure the teams document all experimental work, supporting information, and data appropriately in an electronic lab notebook (eLN)  or batch record in a timely manner. 
  • Manage the compilation and presentation of data to program teams. Participate in program teams, as necessary.
  • Manage the authoring and review of batch records, work instructions, technical reports, statements of work and supporting procedures. 
  • Manage process technical transfer, including generating supportive documentation, training, and technical support to Manufacturing or contract manufacturing organizations.
  • Manage and actively participate in, as required, generating reference standards,  lead  stability samples, forced stability samples, toxicology lots, non-human use (NHU) engineering run lots,  and clinical manufacturing run lots, as appropriate.
  • Author,  review, and provide technical expertise on processes during the preparation of CMC-related regulatory filings for engineered cell medicine programs.
  • Support Quality with required data, technical assessments, and expertise, including contributing to management reviews, material specifications, change controls, CAPAs, deviations, stability plans, specifications, OOS results, comparability assessments, and process validation. 


  • PhD (preferred) in a life science discipline such as Biological Sciences, Biotechnology, Pharmaceutical Sciences, or Biomedical Engineering with 5+ years of relevant experience,  MS with 8+ years relevant experience or BS with 10+ years of relevant experience. 
  • Experience with applicable cellular manufacturing processes.  
  • Experience with iPSC and/or Hematopoietic Stem Cell manufacturing processes highly preferred.   
  • Experience related to the development and/or technical transfer of GMP processes for cellular therapies.
  • Knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles for CGMP operations.
  • 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 building and managing teams effectively.
  • Strong organizational skills with the ability to multi-task, problem-solve, prioritize assignments, and adjust priorities to meet goals in a fast-paced environment.
  • Understanding of product development life cycle and stage gates from research to development to commercial operations preferred.