about the company.
an innovation-driven biotech company specializing in the development and commercialization of high-quality biologics, with a focus on oncology and autoimmune diseases.
about the team.
Global team unites top-tier talent from around the world to translate cutting-edge science into globally accessible therapies
about the job.
- Fully responsible for the daily operations, talent pipeline building, and professional development of the Drug Product Development department;
- End-to-End Drug Product Development. Lead the team to formulate product iteration strategies, driving the development of combination products and lifecycle transitions such as Intravenous to
subcutaneous formulation conversions. - Oversee the drafting, reviewing, and responding to Questions for the formulation and process sections of CMC regulatory dossiers.
skills and experience required.
- Master’s degree or above in Pharmaceutics, Biopharmaceutics, Biochemistry, Chemical Engineering, or related fields (Ph.D. is highly preferred).
- 8+ years of experience in formulation development within the biopharmaceutical industry, including at least 3-5 years of successful team management experience
- Deep technical expertise in formulation development, lyophilization (freeze-drying) process development and scale-up, fill-finish process development and scale-up, process characterization, and combination products. Successfully from IND to BLA/NDA is highly preferred.
