Requirements: English
Company: Thermo Fisher Scientific
Region: Milan , Lombardy
MS&T Director Aseptic Process Simulation / Smoke StudiesJoin to apply for the MS&T Director Aseptic Process Simulation / Smoke Studies role at Thermo Fisher Scientific.Position DetailsWork Schedule: Standard Office Hours (40/wk)Environmental Conditions: OfficePosition: MS&T Director Aseptic Process Simulation / Smoke StudiesReports To: DPD Division MSAT HeadLocation: Remote US / EUPreferred Locations:North Carolina (US): GreenvilleFrance, BourgoinItaly: Monza & FerentinoUK: SwindonThese locations are key sites for our operations.Position SummaryYour outstanding skills will help our sterile sites introduce new products, improve capabilities, and reduce compliance risks.Key ResponsibilitiesManufacturing SupportProvide SME expertise in APS and Smoke Studies for sterile pharmaceutical processes.Establish division strategy and update global standards in collaboration with global Sterility Assurance.Ensure APS and Smoke Studies approaches are consistently applied across the DPD sterile sites.Provide support on APS topics such as design, operational considerations, reducing compliance risk, and execution protocols.Provide expertise in process characterization to increase robustness and sustainability.Assist in troubleshooting and root cause investigations by harmonizing technical processes.Review and improve sterile site aseptic practices and technologies.Collaborate with sterile manufacturing teams to implement new technologies and ensure timely product launches.Monitor GMP, EU, and FDA regulatory changes and review industry journals.Support aseptic manufacturing projects, including equipment and process integration.Provide expert technical support in aseptic manufacturing, validation, new technologies, and sterilization.Identify and drive opportunities for process efficiency and product quality improvements.Develop and align training curricula for site SMEs, ensuring standard methodologies across sites.Stewardship for Aseptic Network & New Product LaunchServe as the Network SME collaborating with local and global MSAT networks and technical development organizations.Define and implement new technical standards for existing and new technologies and equipment.Benchmark internally within DPD and externally in scientific and academic environments to extend knowledge and stimulate innovation.Author and implement GOPs for assigned technologies.Qualifications and RequirementsMSc or equivalent experience in Pharmacy, Pharmaceutical Technology, Chemistry, or a related scientific field.10+ years of professional experience in GMP manufacturing relevant to the specialist area of expertise.Proven process understanding in Pharma, GMP, and Regulatory aspects.Up to 30-40% travel as needed.Confident communicator both verbally and in writing.Able to influence others, build cross-functional teams, and set clear business objectives.Demonstrated leadership and technical experience.#J-18808-Ljbffr