Manufacturing Sciences, Process Scientist II

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description How will you make an impact? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving laboratory efficiency, advancing patient health through diagnostics, or developing and manufacturing life-changing therapies, we are here to support them. We are seeking a highly motivated Process Scientist II to join the Pharmaceutical Development Services (PDS) team in Monza, Italy. The Pharmaceutical Development Services (PDS) division specializes in clinical and small-scale commercial contract manufacturing of sterile injectable drug products, including liquid and lyophilized formulations. You will join the Process Manufacturing Sciences team, where scientists design, develop and optimize manufacturing processes for innovative therapies, working in close partnership with clients and cross-functional teams. This role offers the opportunity to contribute to the successful delivery of life-changing medicines while developing your scientific expertise in a dynamic and collaborative environment. What will you do? As a Process Scientist II , you will support the development, optimization and technology transfer of sterile manufacturing processes into the cGMP manufacturing suites at the Monza site. As the Process Subject Matter Expert (SME) for assigned projects, you will provide scientific leadership throughout the project lifecycle, partnering with clients and cross-functional teams to develop robust, scalable and compliant manufacturing processes for clinical and commercial products. Your responsibilities will include: Define, develop and optimize manufacturing processes for sterile injectable products based on product knowledge, development data and Quality Target Product Profile (QTPP). Prepare and review technical documentation, including manufacturing instructions, study protocols, technical reports, FMEA and GAP analyses. Drive the technical execution of assigned projects, supporting process development, scale-up, technology transfer and manufacturing activities. Build strong scientific partnerships with clients, provide technical expertise and supporting process-related decisions throughout the project lifecycle. Lead technical investigations, risk assessments and process optimization to ensure robust and compliant manufacturing processes. Collaborate with Manufacturing, MSAT, Quality, Engineering and other cross-functional teams to ensure successful project execution. Present scientific data, project progress and technical recommendations to internal stakeholders and external clients. Support client meetings, audits and regulatory inspections as the process technical expert .