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BioNTech SE
Engineer as Team Leader (m/f/d)
• Marburg, 35041
Führungs-/ Leitungspositionen Homeoffice möglich
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[...] 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 clinical [...]
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