When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

How will you make an impact?

Thermo Fisher Scientific is making a significant investment in the dynamic and rapidly growing Cell Therapy space. The candidate will be a part of a Cell Therapy Manufacturing team and will be responsible for manufacturing of cellular therapy products for clinical applications. He/She will be responsible for following Current Good Manufacturing Practices (cGMPs) to carry out end-to-end processing and verification of patient-derived clinical cellular therapy products. These functions may include but are not limited to activities such as processing of blood related products, isolation and propagation of human primary cells, preparation of cell culture media­, culture and expansion of cells in closed systems.

What will you do?

• Execution of manufacturing batch records, work instructions and/or SOPs, with minimal instruction on a day-to-day basis and a focus on proactive ‘right the first time’ executions. Assist with batch record reconciliation and timely documentation.
• Performance of all manufacturing activities in clean room (ISO 7) environment with specialized sterile gowning.
• Execution of cell manufacturing and cell processing activities in closed systems and maintaining aseptic technique during processing to ensure highest integrity, viability and sterility of cellular product until release.
• Work as a part of the team to execute all necessary GMP runs for cell manufacturing in an accurate and timely manner
• Perform accurate and error-free calculations of cell concentrations, cell and media dilutions and cell viability throughout the entire cell manufacturing process workflow.
• Able to execute all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies.
• Acts as On-The-Job-Trainer for a variety of job functions
• Documentation of all activities to meet cGMP requirements. Execute document reviews and revisions. Daily record review, tasks, and databases. Actively provide feedback.
• Critical evaluation of processes, including foresight and thinking ahead.
• Complete preventative maintenance and work notifications tasks on time. Perform equipment testing and routine trouble-shooting.
• Ensure tasks are executed with a method of prioritization - interpret production schedules and complete tasks accordingly.
• Perform timely consumption of materials and completion of quality documentation in appropriate systems
• Identify deviations, aid in investigations/root cause analysis, and provide input on major/critical deviations. · Work to complete documentation of deviations and events in appropriate systems
• Execute validation protocols with minimal supervision or direction
• Participate in cross-functional teams to complete projects

How will you get here?

Education

• High school degree required.
• Bachelor’s degree in Biological Sciences, Medical Technology, Applied Health Sciences or closely related field is preferred.

Experience

• 1-2 years of relevant cGMP experience in a manufacturing pharmaceutical/biotech environment or related areas
• Experience in aseptic cell culture processing in IOS 5 biosafety cabinets while using universal precautions for handling of human-derived materials preferred
• Experience in cell therapy manufacturing required
• Experience in cell therapy automation technologies, closed system culture vessels, cell washers, cell separation technologies for autologous/allogenic product manipulation preferred
• Experience in handling, propagation, isolation, activation and cryopreservation of human primary cells including T cells preferred
• Strict adherence to SOPs, GMP regulations, FDA guidance and ability to accurately complete associated documentation required

Knowledge, Skills, Abilities

• Understanding ‘why’ and not just the ‘how’ of processes and practices
• Knowledge of cGMP practices required
• Knowledge of deviation investigations preferred
• Knowledge of cell culture and aseptic techniques strongly preferred
• Mechanical Skills/ Analytical Skills/Method Automation
• MS Office
• Strong math skills
• Strong prioritization skills
• Detail oriented
• Results driven
• Strong communication skills with ability to read, write, and communicate in English
• Effectively multi-task
• Able to work in an environment of change
• Able to work independently and as part of a team
• Able to recognize problems developing, not just occurring

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.