about the company.
A leading big pharmaceutical Company
about the team.
Leading global scientific team
about the job.
- Serve as a formulation lead to develop a robust formulation and DP process to for early-stage and late-stage biological programs, including antibody and ADC molecules. Responsible for formulation and DP process development and technology transfer.
- Act as a functional representative in cross-functional teams, and collaborate with key stakeholders (BioTD functions, research, CMC, Quality, MST/manufacture, Reg CMC, clinical operation, etc.) to advance the technical development of new biologics entities according to aligned program timeline. Enable IND/NDA/BLA submission per aligned CMC timeline.
- Provide technical support for GMP deviation investigations.
skills and experience required.
- PhD in pharmaceutical sciences, biochemistry, chemical engineering, or relevant field, with 3-10 years of experiences in formulation and/or DP development in the biopharmaceutical industry.
- Proficient experimental skills, able to independently design stability studies, execute experiments, interpret the data and draw scientifically solid conclusions.
- Familiar with formulation methodologies and equipment, such as MFI, DLS, visual inspection, viscosity, etc. is a plus.