Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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:
Join our team at Thermo Fisher Scientific as a Manufacturing Sciences Scientist I, where you'll contribute to our mission of enabling customers to make the world healthier, cleaner and safer. In this role, you'll support manufacturing operations by developing, optimizing and implementing production processes while ensuring compliance with quality standards. You'll collaborate with cross-functional teams to manufacture critical products for diagnostics, research, and therapeutic applications. The position offers opportunities to enhance processes, solve technical challenges, and directly impact patient care through high-quality manufacturing.
REQUIREMENTS:
• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biochemistry, Chemical Engineering, Biotechnology) or related field
• Proven experience in Change Control management within a GMP-regulated environment, preferably in Product & Process Development
• Expertise in drafting, reviewing, and managing Change Controls related to manufacturing processes for clinical (Phase I, II, III) and commercial products
• Experience with sterile products, including liquid and lyophilized formulations, in vials and pre-filled syringes
• Basic knowledge of manufacturing processes and process development activities
• Good knowledge of GMP and GDP requirements
• Hands-on experience with electronic Quality Management Systems, preferably TrackWise
• Ability to perform impact and risk assessments and ensure timely progression of Change Controls
• Strong organizational skills, with the ability to manage multiple activities and priorities
• Strong communication and collaboration skills, with the ability to effectively interact with cross-functional teams
• Fluent in English; additional languages are a plus
COLLABORATION & INTERFACES:
• The role will be part of the Product & Process Development team at the PDS site in Monza
• Close collaboration with Process Scientists and Master Batch Record teams to support Change Control definition and execution
• Active interaction with cross-functional stakeholders, including QA, QC, Manufacturing, and MSAT, to ensure proper assessment, alignment, and timely closure of Change Controls