主要職務:
1. Design and execute R&D study of NDA projects
2. Process development & tech-transfer to CMO.
3. Assist CMC regulatory documents preparation for IND and NDA submission.
詳細職務內容:
1. R&D phase study design for API screening & early phase formulation development.
2. Work with CMO for tech transfer & process development.
3. Collect and draft CMC required information for RA reviewing
4. Execute CMC related experiment when necessary
5. Work with production team. Communicate and provide technical support.
Job responsibilities mainly include
1.Conducting lab experiments involving cell culturing(of immune and cancer cells),molecular cloning, virus packaging, cell transduction, cytotoxicity of effector against target.
2.Analyzing experimental data using methods such as flow cytometry, qPCR, ELISA, Western blot.
3.Scientific writing that includes writing of grant proposals and patent.
4.Administrative duties such as project management.
1. Formulation design of oral, parenteral and topical product.
2. New drug delivery platform development for 505(b)2 candidate.
3. CMC preparation global submission.
4. Patent survey for new candidate and by-pass formulation design.
5. Trouble-shooting of existing commercial products.