MSAT Upstream Scientist III

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.

Essential Responsibilities

• 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.
• Develop sampling plans with internal QC and clients to incorporate into cGMP batch documentation.
• Monitor and trend process performance, including input and output parameters.
• Provide product quality impact assessments and investigate root causes of major deviations for cGMP manufacturing, and implement CAPA for major deviations
• Identifying opportunities to improve systems and practices
• Work with counterparts in BioProcess Sciences, Manufacturing, Quality, Project Management teams etc. to facilitate technology transfer and project success.

Keys to Success: Education/Experience

Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in GMP-regulated pharmaceutical/biotech manufacturing required. Preferred Fields of Study: Chemical Engineering, Chemistry, Biochemistry, Biotechnology, or related scientific field. Experience with adherent mammalian cells (preferably HEK).

Knowledge, Skills and Experience

• Technical expertise in upstream biopharmaceutical manufacturing and/or process development.
• Knowledge of Stirred Tank, single use Bioreactors, flat stock technology including Cellstacks, Hyperstacks and iCellis.
• Expertise in late stage/commercial technology transfer, process validation of biopharmaceutical/gene transfer vector manufacturing preferred.
• Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.
• Knowledge of cell and gene therapy vector production is highly desirable.
• Ability to work both independently and as part of a team.
• Ability to function in a fast-paced dynamic team environment and balance prioritize multiple projects
• Project management skills desirable
• Laboratory skills and the ability to be hands-on.
• Ability to speak effectively before groups of customers.
• Excellent troubleshooting skills and ability to solve complex technical issues.
• Ability to compile, analyze and interpret data; Ability to write routine reports and correspondence.
• Strong interpersonal and communication skills, verbal and written.
• Ability to communicate in a dynamic environment.

Work Environment/Physical Requirements

Standard office environment with some interaction in GMP manufacturing and laboratory settings. May require occasional standing, walking, and use of PPE during client visits or facility tours. This role is based 100% onsite at the Plainville, MA facility.