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Senior Manager
Analytical Development
Posted on 1/12/2023
INACTIVE
Locations
Cambridge, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Requirements
  • Strong background in cell biology and molecular biology
  • Demonstrated ability to develop molecular and cellular assays for cell and gene therapies
  • Experience and/or knowledge of CRISPR/Cas9 gene editing technologies a plus
  • Broad knowledge of new technologies in the biotechnology field and a track record of innovation
  • Experience in leading a team of direct reports and providing guidance and mentorship to junior scientists
  • Experience in leading cross-functional collaborations with other departments (e.g., research, process development, QC) as well as external CROs/CDMOs
  • Knowledge of FDA, EMA and ICH regulations, and understanding of product development life cycle
  • Attention to detail, strong organizational skills, and ability to multi-task, problem-solve, and adjust priorities to meet goals in a fast-paced environment
  • Strong verbal and written communication, time management, record keeping and data analysis skills
  • PhD in life sciences-related discipline with 5+ years of relevant analytical development experience, including 3+ years of industry working experience
  • Travel to support technical transfer efforts, as required
Responsibilities
  • Lead a team of scientists and associates to develop and optimize fit-for-purpose biological assays for identity, gene editing, impurity, potency, etc. of ex vivo CRISPR gene-edited cell therapy products
  • Develop analytical strategy and work plan for the Cell AD team, and provide guidance to direct reports
  • Author and review test methods, technical reports, and supporting procedures
  • Manage analytical method technical transfer from Research into AD, and from AD to internal QC and external CDMOs and CTLs
  • Support QC with required data, technical support (e.g., investigations, specifications, comparability, and assay qualification/validation), and document reviews
  • Support process development and related studies (formulation, stability, shipping, etc.), and characterize drug substances and drug products
  • Lead assessment and implementation of new technologies and assay platforms
  • Participate and present in cross-functional program teams and lead analytical sub-teams
  • Support CMC-related regulatory filings for cell therapy programs by authoring and reviewing documents and providing technical expertise on analytical methods and strategies
Editas Medicine

51-200 employees