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. 

Requirements:

  • 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.