- Manage Pre-formulation group, work closely with Process group and Formulation group to meet project timelines, departmental goals.
- Plan, co-ordinate and oversee the work activities of Polymorph screening, Salt screening and selection, Solid state characterization (PXRD, TGA, DSC, Microscopy, etc.), Solubility determination, Particle size analysis, Recrystallization, pKa determination.
- Support Process group to control particle size of API with recrystallization and milling.
- Support Formulation group to develop new formulations for poorly soluble compounds（such as nano-particles, solid dispersion, microemulsion） to improve bioavailability.
- Quick adapt to new technology and be a technical leader in certain areas.
- Prepare document (Pre-formulation part) for IND and NDA filling.
- D. (or equivalent) in Chemistry, Pharmaceutical Sciences, Chemical Engineering or closely related field preferred.
- 8+ years’ experience in the pharmaceutical or biotech industry.
- Strong technical knowledge of pre-formulation development. Working knowledge of process scale-up and technology transfer, cGMPs, ICH guidelines.
- Excellent interpersonal skills in internal and external (i.e. CMO/CRO management) interactions.
- Excellent communication skills both written and oral.
- Excellent time and project management skill.