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.