Director AS&T mAb & ADC Network

Responsibilities

• Provide overarching analytical support within the China organization and serve as a local interface for clinical and commercial CMC project teams.
• Facilitate analytical transfers and support quality control for mAb and ADC projects by engaging with local collaboration partners, CDMOs, and vendors.
• Provide on-site operational support and troubleshooting at collaboration partner and CDMO sites.
• Review project documentation, including method development reports, analytical procedure protocols, and validation reports, in accordance with regulatory guidelines.
• Drive assigned analytical packages within global technical operations and ensure the translation of technical documents for transfer activities.
• Act as a subject matter expert to support internal audits and Health Authority inspections.

Requirements

• Master’s degree or PhD in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a comparable field.
• At least 5 years of relevant professional experience in an international and highly regulated environment.
• Proven experience in protein and ADC analytical technologies, including physico-chemical and functional assays.
• Strong knowledge of GMP and experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA).
• Excellent project management and communication skills, with the ability to manage cross-functional CMC teams and external stakeholders.
• Experience in analytical activities for late-stage and commercial projects.

Preferred Qualifications

• Knowledge of small molecule analytics is considered a plus.

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We are a community of innovators and scientists working to address high medical needs, such as cancer and infectious diseases, to improve health worldwide.