Req #, Job Title: Formulation Technician II
Location/Division Specific Information
St. Louis, MO/ Drug Substance Division (Biologics)
How will you make an impact?
The candidate will be responsible for the performance of operations in support of the manufacture of Commercial and Clinical Biologics. They will be responsible for following Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to Upstream (cell culture) and Downstream (purification) biopharmaceutical manufacturing. 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), conducting large scale chromatography, viral inactivation, viral filtration, ultrafiltration and diafiltration, as well as aseptic filling of bulk drug substance.
What will you do?
• 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. 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 performed with a method of prioritization - interpret production schedules and complete tasks accordingly.
• Participate in shift exchanges, 1-1's, meetings, attend meetings as vital to facilitate area needs based on changes, etc. (lean activities).
Work Shift: 12HR rotating day shift 6:00am- 6:30pm, night shifts 6:00pm- 6:30am; weekend and holiday work incentives. Guaranteed OT
Starting pay: $21+ depending on experience and education
How will you get here?
Education
High school degree required. Degree in a STEM area of study or equivalent years of experience preferred
Experience
1-3 years relevant lab experience in a related field or industry preferred • Experience in manufacturing and/or GMP environment preferred
Knowledge, Skills, Abilities
Knowledge
• Understanding 'why' and not just the 'how' of processes and practices
• Knowledge of cGMP practices, aseptic techniques, or chemical concepts seen as a plus
Skills
• Mechanical Skills/ Analytical Skills/Method Automation
• MS Office
• Strong math skills
• Strong prioritization skills
• Detail oriented
• Results motivated
Abilities
• Able to read, write, and communicate in English
• Able to understand and carry out instructions
• Reliable
• Strong communication (written and verbal)
• Successfully 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
• Ability to wear all Personal Protective Equipment (PPE), including work uniform, steel toe shoes, hair net, safety glasses, bump cap, and nitrile gloves. PPE may also include face shield, respirator, and smock.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our Globally distributed team of more than 90,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit
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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
