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Editas Medicine Senior Manager, Cellular Process Development in Cambridge, Massachusetts

Key Responsibilities & Accountabilities:

  • Manage teams collaborating with Research to transfer processes into PD.

  • 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.

  • Other responsibilities as required.

Requirements

Knowledge, Skills & Capabilities:

  • 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.

  • Strong verbal and written communication skills.

  • Strong leadership skills.

  • Understanding of product development life cycle and stage gates from research to development to commercial operations preferred.

Education & Relevant Work Experience:

  • BS or MS in a life science discipline such as Biological Sciences, Biotechnology, Pharmaceutical Sciences, or Biomedical Engineering with 8-10 years relevant experience or PhD (preferred) in a life science discipline such as Biological Sciences, Biotechnology, Pharmaceutical Sciences, or Biomedical Engineering with 5+ years of relevant experience.

Physical & Travel Requirements:

  • Some travel required, <20%.
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