(Ass.) Director AS&T mAb & ADC Network

About the Position

Position Summary:

The main responsibility of this role is to provide project overarching analytical support within the China organization and serve as a local interface for all clinical and commercial CMC project teams with Chinese collaboration partners, CDMOs, and vendors.

Specific tasks of this position include engaging directly with local collaboration partners, CDMOs, vendors, etc. to facilitate analytical transfers and support quality control for mAb and ADC projects.

This role also involves supporting operational & troubleshooting activities on-site.

Responsibilities

• On-site operational support at collaboration partners and CDMOs for AS&T and quality control to support analytical transfers (ad-hoc site visits for troubleshooting etc.)
• 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

• 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, 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

We Offer

• Competitive salary
• Opportunity to work in a dynamic and innovative environment
• Professional development opportunities
• Diverse and inclusive workplace

About the Company

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer.

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Apply now - We look forward to receiving your application!

Apply to our Shanghai, China location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).

Job ID 11325 (please always specify if you have any questions)

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

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