- Supervise and support formulation development team to develop, optimize, scale-up, and manufacture clinical trial materials in support of early and late stage clinical studies.
- 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.
- Develop dissolution and performance tests to support formulation screening and optimization. Evaluate enabling technologies for commercial dosage form.
- Work with CMOs or commercial plant to assist gap analysis, risk assessment, tech transfer, process DOE and optimization.
- Coordinate with external collaborators including international Pharmaceutical companies to co-develop formulations and to overlook the projects’ progress.
- Evaluate and manage CMOs to ensure timely delivery of clinical drug products with high quality.
- Draft and review regulatory filing documents of IND and NDA for NMPA/CFDA, USFDA, EMA and TGA.
- Prepare and participate interactive technical meetings with external collaborators and official reviewers in CDE.
- Collaborate with other functional groups in pharmaceutical development, regulatory Affairs, and clinical supply operation and contractors.
- Ph.D in formulation or related fields.
- Over 10 years’ experience in formulation development. Overseas working experience in global pharmaceutical company is preferred.
- Familiar with pharmaceutical industry regulations such as ICH, USP and FDA guidance etc.
- Excellent leadership and management skills, including supervision and mentoring of teams. Good communication and positive interpersonal skills.
- Fluent English (oral and writing) communication skills.