Manufacturing & Mbr Specialist, Mrna Manufacturing Monza

Manufacturing & Mbr Specialist, Mrna Manufacturing
Monza
Lombardia, Monza

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Office

Job DescriptionThermo 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 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.

The Monza site of Thermo Fisher Scientific is seeking a Manufacturing Specialist for the mRNA Manufacturing Process Unit, dedicated to the formulation of mRNA Drug Substances & Drug Products.

The resource will have the incredible opportunity to act as SME of the mRNA Manufacturing Facility, Processes, and Services and will be the main point of contact for implementation of projects and changes.

The Manufacturing Specialist will support the internal Business Teams and collaborate with other functions for the management of:

Process issues, providing knowledge to identify right-first-time root causes and CAPA while supporting the mRNA Quality Team for timely deviations' closure. New Facility/Equipment modifications and any qualification activities. Documentation Manufacturing Readiness activities. The candidate will have the opportunity to showcase their leadership abilities in a diverse and dynamic work setting.

Main Tasks:Lead any Facility/Equipment/Documentation/Process issue in collaboration with Manufacturing & Quality Teams, involving other site functions (i. e. , Maintenance and Calibration, Engineering and Automation, MSAT and Equipment, Computer System, Process and Cleaning Validation). Support the Quality Team on deviation management, providing experience and knowledge to identify right-first-time root causes and CAPA, ensuring timely deviations' closure. Handle Deviation, CAPA, and Change Control records opening. Issue and review documentation needed for manufacturing activities (i. e. , SOPs, Protocols, Report, Technical & Risk Assessment). Collaborate with MSAT to define specifications of new Equipment & Consumables, issuing URS and technical drawings. Manage new implementations/modifications of the mRNA Manufacturing Process Unit, planning and coordinating activities across business & site functions, ensuring effective collaboration with all partners. Plan and supervise externally and internally any new commissioning and qualification activities. Manage CAPA and Change Control implementations. Participate in on-site client visits and EHS and Quality audits. Promote Trainings and Process Courses across mRNA Business. Identify Continuous Improvement & Cost Saving Projects. Minimum Qualifications:Degree in CTF, Chemistry, Biology, or Biotechnology. Confirmed experience in GMP Manufacturing, with strong Quality attitude and solid knowledge of Upstream and Downstream processes for mRNA Drug Substances and Drug Products. Strong communication and leadership skills. Proactive approach, focus on prevention and problem solving. Team Building capability. Italian and Proficient English. Yellow or Green Belt Certification will be a plus. Thermo Fisher Scientific is an Equal Opportunity Employer.

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