MSAT Scientist III, Upstream

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Title: MSAT Scientist III, Upstream 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. Location/Division Specific Information Reporting to the Plainville, MA site and supporting the Viral Vector Services (VVS), a division of Thermo Fisher Scientific. At VVS, we deliver from process development through commercial supply, offering the expertise and resources vital to help clients deliver innovative gene therapies. We are placed at the forefront of our leading and groundbreaking Cell and Gene Therapy business, enabling clients to cure genetic, rare, and otherwise untreatable diseases. Discover Impactful Work: Join our team at Thermo Fisher Scientific as a Manufacturing Sciences Scientist III, where you'll contribute to global health through innovative process development and optimization. You'll provide technical leadership in technology transfer, process validation, and manufacturing support across our facilities. Working at the intersection of R&D and manufacturing, you'll collaborate with cross-functional teams to ensure successful execution of manufacturing processes while driving continuous improvement initiatives. A Day in The Life: Your expertise will be vital in resolving complex technical challenges, conducting investigations, and implementing solutions that maintain our high standards of quality and efficiency. The primary responsibility is the execution of Manufacturing Sciences and Technology activities in support of technology transfer, late stage clinical, PPQ and commercial manufacturing of viral vectors. The individual will serve as Subject Matter Expert in upstream processing.  This position requires close interaction with MS&T colleagues, Project Management, Manufacturing, Quality Assurance, Quality Control, BioProcess Sciences, Engineering, Supply Chain and other departments.  This role will focus on aspects of implementing and profiling robust, scalable and efficient manufacturing processes to produce late-phase human clinical trial and commercial gene transfer vector products.

Lead technology transfer for the upstream cGMP manufacturing viral vectors and other modalities. Collaborate with other sites or clients to ensure success of process transfer and scale up. Ensure effective information flow, risk assessment, timeline execution, issue resolution and documentation for cross-functional teams. Includes authoring detailed process definition and facility fit assessment exercises. MST process leads for Upstream processes, ensuring the materials, strategy and documentation are in place. Collaborate with BPS/QC/QA to develop testing strategy for raw materials and process intermediates. Author and maintain detailed process description/process control strategy documents throughout the lifecycle of a program Author and maintain process risk assessment documents Author PPQ protocols and reports. Oversee execution of PPQ and PPQ related activities Support engineering teams on equipment selection, qualification, and start up activities.