Head Quality Control & Analytical Science and Technology Marburg

Head 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.

Your Profile:

• Technical Expertise: Degree in natural sciences, pharmacy, engineering, or a related field. Strong technical acumen in handling analytical challenges for complex molecules e.g. nucleic acids or proteins. Extensive experience in developing, optimizing, and implementing analytical methods in a cGMP-regulated biotech or clinical production environment.
• Proven Experience: Extensive experience (10+ years) in developing, validating, and transferring analytical methods specific to biotech and clinical manufacturing. Proven track record of successfully navigating regulatory inspections (e.g., FDA, EMA, PAI). Proven experience in effectively managing CMC-QC portfolios of multiple late-stage clinical products including incoming goods, finished product and stability studies & expertise in quality management systems, with a focus on method validation, data integrity, and compliance.
• Regulatory Know-How: In-depth knowledge and hands-on experience of regulatory requirements for clinical and commercial production, including experience with FDA and EMA inspections.
• Analytical Skills: Exceptional problem-solving and decision-making abilities for technical and strategic challenges.
• Leadership Skills: Passion for leading teams, empowering employees, and fostering professional growth and extensive experience managing multidisciplinary teams in a high-stakes, fast-paced environment.
• Communication: Strong interpersonal and communication skills to collaborate effectively with external partners, authorities, and internal stakeholders.

Apply now - We look forward to your application!

Apply to our Marburg, 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).

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!