Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
The Manufacturing & MBR Specialist provides comprehensive support in managing Facility, Equipment, Documentation, and Process–related matters in close collaboration with Manufacturing and Quality teams, engaging additional site functions when needed (e.g., Maintenance & Calibration, Engineering & Automation, MSAT & Equipment, Computer Systems, Data Integrity, Quality Systems, Process and Cleaning Validation).
Main tasks:
- Assist the Quality team in deviation management by contributing expertise to identify accurate, first-time-right root causes and effective CAPAs, ensuring deviations are closed within defined timelines.
- Oversee the initiation and management of Deviation, CAPA, and Change Control records.
- Prepare and review documentation required for manufacturing operations, including SOPs, Job Aids, FORM, BRF, protocols, reports, and technical or risk assessments.
- Issue Master Batch Records for each new manufacturing process in collaboration with MSAT.
- Work jointly with MSAT to define specifications for new equipment and consumables, preparing URS documentation and technical drawings.
- Coordinate the implementation or modification of the mRNA Manufacturing Process Unit, planning and orchestrating activities across site and business to maintain seamless collaboration among stakeholders.
- Plan and monitor new commissioning and qualification activities both internally and externally.
- Partner with the Regulatory team to expedite equipment-related submissions.
- Liaise with Warehouse, QC, Supply Chain, and Manufacturing teams to ensure material readiness.
- Lead the implementation of CAPAs and Change Controls.
- Serve as a Subject Matter Expert during on-site client visits as well as EHS and Quality audits pertaining to the mRNA Manufacturing Facility.
- Strengthen Customer–CDMO relationships by contributing to lessons-learned sessions and supporting Customer–Vendor–CDMO collaboration during equipment qualification activities. Actively participate in technical meetings and provide documented evidence of root cause analyses.
- Promote training initiatives and process-related courses across the mRNA business.
- Identify and champion Continuous Improvement initiatives and Cost-Saving projects.
Minimum Qualifications:
- Degree’s in CTF, Chemistry, Biology or Biotechnology.
- At least 2 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 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.