Your New Company
This is a Company with a high reputation in Shanghai. They provide an innovative and supportive working environment and actively encourage career development. Due to the company's growth and future expansion, they are looking for a CMC Head.
Your New Role
1.Strategic thinking and research skills to reduce complicated drug clinical effects into simple clear analytical attributes at the cellular or molecular levels, hence defining the quality of the drug.
2.Innovation skills in development of cutting-edge cell-based assays, molecular biological assays and immunoassays in support of therapeutic antibody or other biotech product portfolio.
3.Gradually manage a team of junior scientists to conduct bioassay development, qualification / validation and sample testing for lot release, in-process, stability and R&D samples under a GMP environment until established as part of a clinical control system.
4.Transfer, training, and trouble-shooting of cell-based assays to collaborating QC labs
5.Represent the department in CMC team for selected integrated and standalone projects.
6.Draft and review regulatory submissions including INDs and BLAs. Interaction with regulatory agencies such as US FDA and China NMPA on a regular basis.
What you'll need to succeed
1.PhD background in Biochemistry / Biotechnology, Cell Biology, Immunology or related field.
2.Solid leadership with at least 5 years’ team management experience.
3.Strong technical innovation and trouble-shooting skills in cell biology, molecular biology and biochemical research.
4.In-depth knowledge with cellular models of diseases, protein interaction, immunoassay, flow cytometry, cell signal transduction, immune regulation and mammalian cell culture.
5.Excellent spoken and written communication skills in English is a must.
6.Experience with regulatory filings preferred.
What you'll get in return
1.Stable development platform
2.Positive working atmosphere
3.Excellent working partner
What you need to do now
If you are interested in this position, please contact Emma Guo via email@example.com or +8618301987576 for more details.
If the job isn't suitable for you, but you're looking for a new position, please get in touch and we'll discuss your career in confidence.