Director AS&T, mAb & ADC Network

BioNTech SE

Director AS&T role providing analytical and quality control support for mAb and ADC projects at BioNTech in Shanghai. Engage with partners and ensure regulatory compliance while supporting operational activities.

Posted 4/19/2026full-timeShanghai • 🇨🇳 ChinaLeadWebsite

About the role

Key responsibilities & impact

Provide project overarching analytical support within the China organization
Serve as a local interface for all clinical and commercial CMC project teams with Chinese collaboration partners, CDMOs, and vendors
Engage directly with local collaboration partners, CDMOs, vendors, etc. to facilitate analytical transfers and support quality control for mAb and ADC projects
Support operational & troubleshooting activities on-site
Review project documentation, including method development reports, analytical procedure protocols, method qualification/validation reports, according to regulatory guidelines
Independently drive assigned analytical packages within global technical operations
Ensure translation of technical documents for analytical transfer activities
Organization of technical visits at collaboration partners, CDMOs or vendors
Subject matter expert support for internal audits and Health Authority inspections

Requirements

What you’ll need

Master’s degree or preferably 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 (physico-chemical assays, functional assays, quality control)
Knowledge in small molecule analytics is considered a plus
Experience in analytical activities of late-stage and commercial projects
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

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

analytical supportprotein analytical technologiesADC analytical technologiesphysico-chemical assaysfunctional assaysquality controlmethod developmentmethod qualificationmethod validationGMP knowledge

Soft Skills

project managementcommunication skillsnegotiation skillscross-functional collaborationstakeholder engagement

Certifications

Master’s degreePhD