Beschreibung

In this role, you will oversee manufacturing and MSAT operations, ensuring timely production and compliance with regulations. Your day-to-day responsibilities will involve leading teams, optimizing processes, and collaborating closely with quality and regulatory teams.

Anforderungen

• •Advanced degree in Biotechnology, Bioprocess Engineering, Chemical Engineering, or related life sciences field
• •Proven leadership experience in MSAT and manufacturing within a GMP-regulated biopharmaceutical environment, ideally in biologics or ATMPs space
• •Strong expertise in upstream and downstream bioprocessing and related analytical methods, ideally using viral vectors
• •Experience in sterile drug product manufacturing, including F&F operations
• •Solid understanding of regulatory guidelines and experience supporting audits and inspections
• •Experience with digital manufacturing systems (LIMS, eBR, SAP, automation platforms) would be desired
• •Strong communication, problem-solving, and organizational skills with a hands-on, solution-oriented mindset
• •High skills in written and spoken English; German would be a plus

Aufgaben

• •Organize manufacturing and MSAT operations for timely and budget-friendly production
• •Lead upstream, downstream, fill-finish, and support manufacturing to ensure safe and compliant delivery of products
• •Develop the MSAT function, focusing on technology transfer, process validation, lifecycle management, and troubleshooting
• •Drive process optimization and scale-up/scale-down activities
• •Conduct process characterization and continued process verification
• •Ensure compliance with GMP regulations and global regulatory requirements
• •Support investigations, deviations, CAPAs, risk assessments, and root cause analyses in collaboration with QA, QC, and Regulatory Affairs

Tools & Technologien

Benefits