Sr. Scientist/Principle Scientist, – Purification Process Development and Formulation
- Build and lead the purification process development and formulation team for biologics (therapeutic antibodies, ADCs, bispecifics, Fc-fusion proteins etc), support manufacturing plant design and construction.
- Responsible for generation of high quality ETS materials for PK/PD, biophysical/bioanalytical and animal studies. Able to identify and resolve key technical issues during the project development.
- Skilled at the risk and project management.
- Support purification and formulation 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 purification process development and formulation.
- Led a variety of purification process development and formulation projects from initiation to FIH.
- Strong expertise in purification process development，including various chromatographic methods (affinity, IEX, HIC, SEC), automation, column packing, resin selection, and instruments (AKTA Avant, Pure, Pilot). Strong expertise in HCP, HMMS, DNA, viral, and aggregates removal.
- Strong expertise in biologics formulation, especially in handling challenging projects such as high concentration (>100 mg/ml), unstable, or viscous biologics.
- Design and perform DoEs to optimize the purification protocol and shorten the process timeline.
- Pilot large scale purification and technical transfer for downstream bioreactor process.
- Author and review relevant CMC sections for IND application and provide technical oversight for responses to regulatory agency comments and recommendations.
- Managerial and leadership experience in building and developing a purification process 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