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Engineer as Team Leader (m / f / d)
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BioNTech SEMarburg, Hessen, GermanyHead Quality Control & Analytical Science and Technology Marburg
Marburg, Germany | full time | Job ID : 8846
Are you a visionary leader with a passion for ensuring quality and analytical excellence in the dynamic world of biotechnology? Then you’re exactly who we’re looking for!
As the Head Quality Control & Analytical Science and Technology Marburg you will lead and develop the Analytical Science & Technology (AS&T) and Quality Control (QC) departments at our manufacturing site Marburg.
Your mission is to build and continuously improve analytical methods and quality control systems, ensuring product quality at every stage of production. You will ensure compliance with all regulatory and cGMP requirements while fostering a culture of collaboration and innovation.
By optimizing analytical and quality control processes, you will enhance the efficiency and effectiveness of our clinical and commercial production pipelines, securing the high standards of pharmaceutical manufacturing.
Your Responsibilities :
- Strategic Leadership : Lead and develop multidisciplinary teams within AS&T and QC. Cultivate a culture of scientific and operational excellence, fostering cross-functional collaboration and innovation.
- Delegated Responsibilities (per §12 AMWHV) & Operational Excellence : Supervise routine testing for raw materials, intermediates, and finished products, ensuring timely documentation and analysis of results. Monitor and approve deviations, changes, and CAPAs.
- Regulatory & Compliance Excellence : Ensure robust data integrity practices and compliance with global regulatory standards (cGMP, ICH, FDA, EMA). Lead preparations and act as key point of contact for regulatory inspections and audits, including FDA, EMA, and PAI, ensuring a state of readiness at all times.
- Method development & Validation : Oversee the development, optimization, and transfer of analytical methods for raw materials, intermediates, and finished products that meet the complex requirements of clinical and commercial manufacturing
- Interfaces & Collaboration : Partner with external stakeholders, including CROs, CMOs, and regulatory agencies, to ensure seamless execution of analytical and quality operations. Provide technical expertise for regulatory submissions, ensuring robust documentation.
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