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 analytical challenges, growing productivity 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, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
The Monza site of Thermo Fisher Scientific is seeking for a Manufacturing Specialist, for mRNA Manufacturing Process Unit, dedicated to formulation of mRNA Drug Substances & Drug Products.
The resource will act as SME of the mRNA Manufacturing Facility, Processes and Services and will be the main point of contact for implementation of any projects and change related to mRNA Manufacturing Process Unit.
The Manufacturing Specialist will support the internal Business Teams and collaborate with other site functions for the management of:
- Process issues, providing own knowledge to identify right-first-time root causes and CAPA and supporting mRNA Quality Team for the on-time deviations closure,
- New Facility/Equipment modifications and any qualification activities,
- Documentation Manufacturing Readiness activities.
The resource will have the chance to prove his/her leadership skills in a highly dynamic and result-driven environment.
**Main Tasks**:
- Manage 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 Quality Team on deviation management, providing experience and knowledge to identify right-first-time root causes and CAPA, ensuring on-time deviations closure,
- Manage Deviation, CAPA and Change Control records opening,
- Issue and review documentation needed for manufacturing activities (i.e., SOPs, Protocols, Report, Technical & Risk Assessment),
- Issue in collaboration with MSAT Master Batch Records for each new manufacturing process,
- Collaborate with MSAT to define specifications of new Equipment & Consumables, issuing URS and technical drawings,
- Manage new implementations / modifications of mRNA Manufacturing Process Unit, planning and coordinating activities across business & site functions, ensuring effective collaboration with all stakeholders,
- Plan and monitor externally and internally any new commissioning and qualification activities,
- Manage CAPA and Change Control implementations,
- Participate to on-site client visits and to EHS and Quality audits related to mRNA Manufacturing Facility,
- Promote Trainings and Process Courses across mRNA Business,
- Promote and Identify Continuous Improvement & Cost Saving Projects.
**Minimum Qualifications**:
- Degree's in CTF, Chemistry, Biology or Biotechnology,
- At least 3 years of experience in GMP Manufacturing, with strong Quality mindset 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 Fluent English,
- Yellow or Green Belt Certification will be a plus.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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