Senior Research Scientist

Job Description:
1)PhD in biochemistry, biotechnology，pharmacy related scientific discipline, more than 5 years’ experience in macromolecule biological medicine process development, commercial production or quality analysis etc.
2) Experience in production workshop design and construction is preferred; Experience in process validation is preferred
3)Have many years of experience in managing CMC team.
4)Working experience in well-known CMO company and senior management position is preferred.
5)Familiar with the standard and quality standard requirements of GMP for biological medicine production in USA, EU, and China; E Be familiar with and participate in the registration process；Experience with EMA or FDA certification is preferred.
Requirements:
1)Responsible for the development of the fermentation, purification and preparation process of antibody drugs, technology transfer and amplification.
2)Responsible for the construction and optimization of process development technology platform;
3)Manage the development process and project execution of biological medicine process to
ensure project quality and progress;
4)Responsible for the management and training of the process team, and set up an efficient and good working atmosphere;
5)To guide and optimize process technical solution and solve related technical problems;
6)To guide the filing and writing of related patents and articles;
7)Responsible for the process development and production of related IND declaration materials;
8)Support the project management department to complete related plans and tasks;
9) Support r & d department to optimize the development of bio-drug development and pharmacodynamics.