Senior MSAT (Manufacturing Science & Technology) Expert - Drug Product, Greenfield Project

Senior MSAT (Manufacturing Science & Technology) Expert - Drug Product, Greenfield Project

Lonza

Stein, Switzerland

Key responsibilities:

• Act as the MSAT expert in capital investment projects to build and commission manufacturing units, ensuring commercial readiness for the GMP manufacturing facility;
• Define qualification strategies and concepts for DP manufacturing equipment and clean rooms as part of the aseptic fill&finish lines in alignment with regulatory requirements (e.g EU GMP, FDA, ICH). Lead and act as a MSAT member in cross-functional project teams (e.g QA, Engineering, Manufacturing, QC);
• Provide technical leadership during the design of the sterile manufacturing processes, including cleanroom layout, material/personnel flow, and equipment placement;
• Craft the Aseptic Process Simulation concept in alignment with internal guidelines and regulatory requirements. Provide oversight and technical support during execution of APS and all investigations regarding the aseptic manufacturing process. Support the development of aseptic technique training programs;
• Lead risk assessments (e.g FMEA) to identify critical manufacturing process parameters and control strategies for the facility. Author and review GMP documents such as Qualification/Validation master plans, protocols and reports, SOPs, manufacturing concepts, etc.;
• Ensure GMP documentation readiness for authority inspections in line with internal and external quality standards;
• Contribute to the development and implementation of standardized MSAT procedures and processes, including qualification standards, single-use systems, and filtration systems.

Key requirements:

• University Degree or equivalent technical education in Biotechnology, Pharmacy, or a related field;
• Significant experience in aseptic/sterile fill&finish processes of drug products in a GMP environment is a must, with substantial know-how in aseptic processing and sterility assurance principles;
• Experience in qualification of manufacturing equipment, cleaning validation, and room qualification is an asset;
• Strong communication skills, able to translate complex technical topics into clear actionable messages;
• Proactive, positive approach, problem-solving attitude, and ability to take full responsibility for assigned areas;
• Ability to lead cross-functional teams and drive decision-making in a matrix organization; build strong networks and trust across internal and external stakeholders;
• Proficiency in English is a must; German language skills are a plus.

We are looking for someone who can find the best scientific solutions and efficiently implement them in real-world scenarios. If you are ready to collaborate at an outstanding level and deliver magnificent results, we would love to hear from you!