Mainz, Germany | full time | Job ID: 9106

As the Director of Global MS&T – Drug Substance, you will be the Manufacturing Process Owner for a diverse portfolio of modalities, including mRNA, monoclonal antibodies (mAbs), and antibody-drug conjugates (ADCs).
Your expertise will be instrumental in industrializing robust, scalable, and GMP-compliant manufacturing processes. Leading a team of subject matter experts (SMEs), you will work cross-functionally to ensure the successful transfer, validation, and optimization of manufacturing processes across BioNTech’s global network.

Key Responsibilities:

Manage and mentor a team of SMEs in Drug Substance manufacturing, fostering a culture of technical excellence and innovation.
Oversee process lifecycle management for mRNA, mAbs, and ADCs, ensuring processes are robust, efficient, and compliant with global regulatory standards.
Drive the industrialization of manufacturing processes to full-scale commercial production.
Ensure all processes meet GMP requirements and are inspection-ready for global health authorities.
Execute technology transfers between development and commercial manufacturing sites, ensuring seamless integration into operations. Support process implementation at manufacturing sites through on-site support e.g. Person-in-Plant
Utilize data-driven methodologies to improve process robustness, efficiency, and yield while maintaining high product quality.
Partner with internal and external stakeholders, including CMC Development, Quality, Regulatory, and Manufacturing Operations, to drive strategic objectives.

Your Profile:

Advanced degree (PhD, MSc, or equivalent) in Biotechnology, Bioprocess Engineering, Pharmaceutical Sciences, or a related field.
10+ years of experience in biopharmaceutical manufacturing, with a strong track record in MS&T and drug substance process ownership.
Expertise in multiple modalities, including mRNA, monoclonal antibodies, and ADCs.
Proven ability to execute technology transfer, process validation, and scale-up activities.
Strong knowledge of cGMP, regulatory guidelines (EMA, FDA, ICH), and Quality by Design (QbD) principles.
Exceptional leadership skills with experience building and managing high-performing teams.
Excellent problem-solving, analytical, and communication skills, with the ability to engage effectively with cross-functional teams.

Your Benefits:

It's our priority to support you:

Your flexibility: flexible hours | vacation account
Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
Your health and lifestyle: Company bike
Your mobility: Job ticket | Deutschlandticket
Your life phases: Employer-funded pension | Childcare

Apply now - We look forward to your application!

Apply to our Mainz, Germany 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 12 PM to 4 PM CET).

Job ID 9106 (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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BioNTech, the story

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. The main thing is that you suit us, and we suit you!

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Director MS&T Drug Substance