Shanghai Associate Director, External QC Network China SH 200050

Job description

Associate Director, External QC Network China Shanghai, China | full time | Job ID: 11516 Your contribution: Represent External QC Network at CMOs (predominantly located in China) ensuring QC and GMP requirements of BioNTech are considered Represent external/global QC in multidisciplinary project team and define QC project strategy in related projects Oversees the stability program of late development projects. Ensures that stability programs are implemented and adhered to and that results are reported and evaluated. Oversee QC activities at CDMOs and ensure delivery of QC-associated work packages (data evaluation, deviation/OOS-investigations, CoA generation and release) in time and quality Act as link between global External QC Network team and Chinese CMOs Participate in generation and approval of QC-related GMP-documentation Management of full QC-value chain for relevant projects/products A good match: University degree in a scientific/life-science-related field (PhD) Minimum of 5-7 years of experience in responsible positions in QC (ideally including analytical development) within the pharmaceutical industry Profound experience in CMC development, including commercialization and stewardship of commercial products Experienced in interaction with Chinese, European and US pharmaceutical companies Experience in managing CDMO networks globally Strong analytical background with antibodies and ADCs Analytical background in chemical synthesis (Linker payload synthesis) is a plus Previous experience in a function leadership role Strong communication as well as (self-)organizing skills Fluent English (both oral and written)