Location/Division Specific Information:
St. Louis, MO
Thermo Fisher places a strong emphasis on employee development, fostering an inclusive culture that values diversity, collaboration, and continuous learning. They are committed to corporate social responsibility, focusing on sustainability, community involvement, and ethical practices. The company recognizes and rewards its employees' achievements, providing a supportive and motivating work environment.
About the Role
The candidate will help the performance of operations in support of the manufacture of Commercial and Clinical Biologics. They will follow Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to Upstream (cell culture). These functions may include but are not limited to activities such as propagation of mammalian cell culture, conducting aseptic cell culture operations, execution of large scare production bioreactors (50L - 2000L), and conducting large scale filtration or centrifugation.
Responsibilities:
- Execution of manufacturing batch records, work instructions and/or SOPs, with focus on proactive ‘right the first time’ executions. Assist with batch record reconciliation.
- Assist in all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies.
- Documentation of all activities to meet cGMP requirements. Complete document reviews and revisions. Daily record review, tasks, and databases. Participate/Lead in shift exchanges, 1-1’s, meetings, attend meetings as needed to facilitate area needs based on changes, etc. (lean activities).
- Support a quality investigation by answering questions and making suggestions for improvement.
- Practices and promotes safe work habits and adheres to safety procedures and guidelines.
- Critical evaluation of processes, including foresight and thinking ahead.
- Ensure tasks are performed with a method of prioritization - interpret production schedules and complete tasks accordingly.
Requirements
Education:
- HS Diploma or equivalent required
Experience:
- Required: Minimum of 2 years of work experience in manufacturing, operation, production, lab setting or related field
- Preferred: Experience in a cGMP environment
Knowledge:
- Knowledge of cGMP practices, aseptic techniques, or chemical concepts- preferred
- Subject Matter Expert on upstream processing steps- preferred
Skills:
- Critical thinking and problem solving
- Strong math skills
- MS Office
Abilities:
- Able to demonstrate practical knowledge with successful outcomes
- Able to recognize problems developing, not just occurring
- Able to read, write, and communicate in English
- Able to understand and carry out instructions
- Be willing to wear a full gowning suit which includes bodysuit, gloves, hair & beard nets, face covers, and safety glasses. (These items are prohibited: makeup, jewelry, nail polish, cologne / perfume, scented lotions or hair care products, etc.)
