Summary:
The main responsibilities are the relevant work of clinical in use (CIU) study based on CIU center of excellence (COE), ensuring compliance with regulatory standards, including study design, study execution, related research and other work related to the construction of CIU COE platform.
Job Responsibilities:
The detailed responsibilities include but are not limited to the following:
Responsible for establishing and maintaining the knowledge platform for CIU.
Designing clinical in-use study protocols according to project characteristics, solving problems encountered in the course of the project.
Communicating with clients in a timely manner for technical communication and reporting, as well as ensuring the timeliness and accuracy of delivery of study reports.
Executing experiments according to the study protocol, including CIU experiments, sample testing, data analysis, etc.
Stay updated on evolving regulatory requirements for biologics, especially for clinical in-use.
Procurement and management of standards, materials and consumables.
Promoting new technologies and advertising business of CIU COE.
Complying with Quality System, EHS and Compliance Requirements.
Candidates willing to work in multiple cities such as Shanghai, Suzhou, Wuxi, and Hangzhou will be given priority.
Education:
M.S. Degree with 2+ years of experience or Ph.D in technical field, better major in pharmacy, biology science, etc.
Experience:
Minimum 2-year experience in biological formulation and process development (industry or academia).
Experience in CIU studies or clinical trial operation is preferred.
Skills:
Familiar with formulation and process development of biological drug products.
Fluent in both Mandarin and English. Strong skills in scientific writing and presentation.
Good communication skills, able to have clear and precise conversations in problem-solving.