Work Schedule Standard (Mon-Fri)
Environmental Conditions Office
Job Description Thermo Fisher Scientific Inc. is the world leader in serving science. Whether our customers are accelerating life sciences research, solving analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics, or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team delivers an outstanding combination of innovative technologies.
ThermoFisher mRNA unit in Monza is looking for a MSAT Scientist role!
What will you do? As a member of the Manufacturing Science & Technology Team, the resource will lead the successful transfer, scale up, supervision and optimization of bioprocesses. You are regarded as a senior expert in process science and manufacturing aspects. In this role, you significantly contribute to the development of the MSAT toolbox and share the manufacturing responsibility as a long-term process owner. Leading multi-functional teams as a process expert tasked with technology transfers (process design and up-scaling) and timely process implementation at manufacturing scale. This includes the whole lifecycle of assigned projects from planning over coordination, implementation, control and project completion aligned with project management goals. Responsible for execution of GMP risk analysis for the manufacturing processes. Act as the interface between the process donor (customer, process development) and operations. Responsible to ensure process scalability and manufacturability. Work with Project Manager and Core Team to lead the Technology Transfer from Process Development, other sites and/or Client to Clinical and Commercial Manufacturing, ensuring effective information flow, timeline execution, issue resolution and documentation in accordance with governing tech transfer quality system requirements while demonstrating robust risk management practices. Writing of Technical documents such as Process GAP Assessment, Technology Transfer Protocol and Sampling Plans, Technical Reports, FMEA, Risk Assessments, VMP and other documents for PPQ campaign and product commercialization. Provide technical and scientific support to any manufacturing process related events such as manufacturing deviations, technical solving, change control and for continuous improvement of process performance. Contributing to the development and implementation of standardized MSAT procedures and processes. Supervising tasks around MSAT initiatives or leading major task forces or troubleshooting teams. Performing process specific trainings for production staff. Education/ Experience MS in the life sciences, engineering, or equivalent technical field required with preferred 2+ years of experience in MSAT roles. Knowledge, Skills, Abilities Proven manufacturing technical skills and experience in Nucleic Acids, Biologics, or vaccine production. Progressed experience in main Upstream (Media Preparation and Enzymatic reactions in Bioreactors) and in Downstream steps (TFF, Chromatography, Encapsulation, Clarifications/Filtrations). cGMP knowledge and process engineering experience. A sound understanding of RNA production and analytics, scale-up principles, process validation, and regulatory strategies. Thermo Fisher Scientific is an Equal Opportunity Employer.
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