1. Supervise and support formulation development team to develop, optimize, scale-up, and manufacture CTM in support of IND, early and late stage clinical studies.
2. Work with pre-clinical and CMC teams to characterize candidate compounds through pre-formulation studies and to develop toxicological formulations and clinical formulations for IND submission and first-in-human trials.
3. Develop dissolution strategy to support formulation screening and optimization. Evaluate enabling technologies for commercial dosage form.
4. Work with CMOs or commercial plant to assist gap analysis, risk assessment, tech transfer, process DOE and optimization.
5. Coordinate with external collaborators including international Pharmaceutical companies to co-develop formulations and to overlook the projects’ progress.
6. Evaluate and manage CMOs to ensure timely delivery of CTMs with high quality.
7. Draft and review regulatory filing documents of IND and NDA for NMPA, FDA, EMA and TGA, etc.
8. Prepare and participate interactive technical meetings with external collaborators and official reviewers in CDE.
9. Collaborate with other functional groups in pharmaceutical development, regulatory affairs, and clinical supply operation and contractors.
1. Ph. D in pharmaceutical science or related fields.
2. Over 5 years’ experience in formulation or drug product development. Overseas working experience in global pharmaceutical company is preferred.
3. Familiar with pharmaceutical industry regulations such as ICH, NMPA and FDA guidance etc. IND and NDA experience for FDA or EMA is preferred.
4. Excellent leadership and management skills, including supervision and mentoring of teams. Good communication and positive interpersonal skills.
5. Fluent English (oral and writing) communication skills.