Head Quality Control & Analytical Science and Technology Marburg(m/w/x)

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 **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 Job ID 8846 (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.