Sr. Scientist/Principle Scientist, Head of Cell Line Development

Status: 
Full Time
Location: 
Boston, MA

Description:

  • Build and lead the cell line development and large-scale expression (10-100 L) team.
  • Responsible for generation of stable GMP cell lines from vector construction to single clone selection. Provide high quality stable GMP cell lines (titer 2-5 g/L) for downstream process development. Able to identify and resolve key technical issues during the project development.
  • Skilled at the risk and project management.
  • Support the manufacturing plant design and construction.
  • Support cell culture related projects FDA submissions, ensure the compliance with the regulatory requirements.

Education:

PhD is required in Molecular biology, Cell Biology, Protein Chemistry, Immunology and other related fields.

Experience:

  • At least 5 years’ industry experience in cell line development and large scale expression fields.
  • Led multiple cell line development projects from initiation to clinical stage.

Qualifications:

  • Strong expertise in cell line development,including vector construction, transfection,amplification,limited dilution, master cell bank establishment, and single clone selection to generate stable GMP cell lines (titer: 2-5 g/L).
  • Design and perform DoEs to optimize media and feed components at small scale.
  • Pilot large scale expression (10-100 L) and technical transfer for downstream bioreactor (up to 2000 L) experiments.
  • Author and review relevant CMC sections for IND application and provide technical oversight for responses to regulatory agency comments/recommendations.
  • Managerial and leadership experience in building and developing a cell line development team. Capable to provide coaching and mentor-ship.
  • Be highly accountable.

 

We offer competitive compensation package, for additional information, please contact: info@qlb-bio.com