MSAT Scientist III, Upstream

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.

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.

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.

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.

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.
• 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: 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.