Job vor 2 Tagen bei Jobvector gefunden
BioNTech SE
Engineer as Team Leader (m/f/d)
• Marburg, 35041
Führungs-/ Leitungspositionen Homeoffice möglich
Jobticket
Head Quality Control Analytical
Science and Technology Marburg Marburg, Germany full time Job ID:8846Are you a visionary leader with a passion for ensuring quality and analytical excellence in the dynamic world of biotechnology? Then youre exactly who were looking forAs 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. 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 [...] 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. 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 [...]
Alle Team Leader Stellenangebote anzeigen
