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.