Sr. Scientist/Principle Scientist, Head of Cell Line Development
- 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.
PhD is required in Molecular biology, Cell Biology, Protein Chemistry, Immunology and other related fields.
- 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.
- 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: firstname.lastname@example.org