In this role, you lead and develop a team of experts while managing the lifecycle of manufacturing processes. You focus on driving industrialization and ensuring compliance with regulatory standards through data-driven improvements and strategic partnerships.
Anforderungen
- •Advanced degree in Biotechnology
- •10+ years of experience in biopharmaceutical manufacturing
- •Expertise in mRNA, antibodies, and ADCs
- •Ability to execute technology transfer
- •Strong knowledge of cGMP and regulatory guidelines
- •Exceptional leadership skills
- •Excellent problem-solving and analytical skills
Deine Aufgaben
- •Manage and mentor a team of SMEs
- •Oversee process lifecycle management for mRNA, mAbs, and ADCs
- •Drive industrialization of manufacturing processes
- •Ensure adherence to GMP requirements
- •Execute technology transfers between sites
- •Provide on-site support for process implementation
- •Utilize data-driven methodologies for process improvement
- •Partner with stakeholders to achieve strategic objectives
Deine Vorteile
Flexible Arbeitszeiten
Digital Learning
Leistungs- und Talententwicklung
Führungsentwicklung
Ausbildungsplätze
LinkedIn Learning
Stimme im Unternehmen
Kultur auf Augenhöhe
Gestaltungs- und Einflussmöglichkeiten
Unterstützung für volles Potenzial
Betriebsfahrrad
Jobticket
Deutschlandticket
Arbeitgeberfinanzierte Altersvorsorge
Kinderbetreuung
Original Beschreibung
# Director MS&T Drug Substance
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
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