About this role
About the Role BioNTech is seeking a leader to build and manage a high-performance Mass Spectrometry (MS) characterization team in Zhuhai. The role focuses on advancing characterization platform capabilities and guiding product characterization strategies for BsAbs and ADC projects from early research through IND/BLA readiness, aligning with development and regulatory goals. What You'll Do
- Lead and build a high-performance MS characterization team, driving platform capability development including instruments, methods, and team capabilities.
- Define and execute product characterization strategies across early research to BLA submission for BsAbs and ADC programs, including developability assessment, IND/BLA stage characterization, process development and optimization, comparability studies, CQA assessment, and complex issue resolution.
- Prepare and review technical reports and regulatory filing documents (IND, BLA) in both Chinese and English to ensure regulatory data readiness.
- Collaborate with CMC, Regulatory Affairs, Project Management and global teams to efficiently advance programs. What We're Looking For
- Education: Master's or PhD in Proteomics, Biochemistry, Analytical Chemistry or related field.
- Experience: 6+ years of hands-on characterization analysis for therapeutic antibodies (BsAbs/ADC); 3+ years of proteomics hands-on experience; 3+ years of technical team leadership.
- Language: Proficient in spoken and written Chinese and English.
- Deep expertise in BsAb/ADC characterization including protein structure characterization; HCP identification and quantification; PTMs and sequence variant analysis; in-depth characterization of bispecifics, ADCs and conjugates, impurities or variants.
- Familiar with multiple orthogonal analytical techniques (HPLC, CE, iCIEF, ELISA, BLI/SPR, CD, DSF/DSC, DLS, AUC).
- Strong analytical and problem-solving skills; able to troubleshoot independently.
- Mature experience in IND and BLA filings (involvement in ≥8 IND projects and ≥1 BLA project).
- Solid technical leadership experience; self-driven with strong teamwork and the ability to empower team members and elevate overall capability.