Manufacturing & Mbr Specialist, Mrna Manufacturing
Pubblicato il 21-08-2026 - Altro in Italia
Experteer Overview In this role you will support the mRNA Manufacturing Process Unit to ensure compliant, efficient production of mRNA Drug Substances and Drug Products. You work as a SME, coordinating projects and changes across site functions to keep operations running smoothly. You'll address process issues, drive CAPA and deviation closure, and support qualification activities. This position offers leadership exposure in a dynamic, outcomes-driven environment with a focus on continuous improvement and collaboration.
Retribuzione / Benefits Manage facility, equipment, documentation and process issues with cross‐functional teams (Maintenance, Engineering, MSAT, Quality)
Support deviation management, identify root causes, ensure on‐time CAPA closure
Open and review Deviation, CAPA and Change Control records
Prepare and review manufacturing documentation (SOPs, Protocols, Reports, Risk Assessments)
Work with MSAT to define equipment and consumable specifications, URS, and drawings
Oversee new implementations/modifications of the mRNA process unit, coordinating across functions
Plan and monitor commissioning, qualification activities (externally and internally)
Lead CAPA and Change Control implementations
Participate in on‐site client visits and audits related to the facility
Promote trainings and process courses within the mRNA business
Pursue continuous improvement and cost‐saving projects
Responsabilità 3+ years GMP manufacturing experience with strong quality mindset
Solid knowledge of upstream and downstream processes for mRNA Drug Substances and Drug Products
Strong communication and leadership skills
Proactive, prevention‐focused problem solving
Team‐building capability
Italian and Fluent English
Yellow or Green Belt Certification a plus
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