Provide project overarching analytical support within the China organization
Serve as a local interface for all clinical CMC project teams with Chinese collaboration partners, CDMOs, and vendors
Engage directly with local collaboration partners, CDMOs, vendors, etc. to support analytical development and quality control for protein and ADC projects
Support operational & troubleshooting activities on-site
Support technical transfers to in-China and ex-China sites
Conduct internal audits and Health Authority inspections
Collaborate with Product Supply and Quality counterparts to enable efficient technical project handover to commercial operations

Master’s degree or preferably PhD in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a comparable field with at least 5 years of relevant professional experience in an international and highly regulated environment
Proven experience in protein and ADC analytical technologies (physico-chemical assays, functional assays, quality control); knowledge in small molecule analytics is considered a plus
General experience in CMC development of early
and late-stage projects, including strategy definition and strategy execution, with a sound understanding of all stages in the drug development process
Sound GMP knowledge and experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA)
Excellent project management skills, capable of working in cross-functional CMC teams and with external stakeholders
Excellent communication and negotiation skills as well as ability to communicate complex technical matters concisely to various stakeholders.

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base.

Associate Director – Protein & ADC Analytics

Key skills