
Lead Formulation Technician
Required skills
- Second Shift
- GMP
- SOPs
- batch records
- logbooks
- cGMP
- preventative maintenance
- quality documentation
- deviations
- root cause analysis
Nice to have
- HS Diploma/ GED
- aseptic techniques
- chemical concepts
- Subject Matter Expert
- training
- guiding employees
Role summary
Thermo Fisher Scientific is seeking a Lead Formulation Technician for their St. Louis, MO facility. This role focuses on upstream processing in biologics manufacturing, involving tasks such as executing batch records, maintaining equipment and supplies, documenting activities to meet cGMP, performing maintenance and troubleshooting, managing material consumption, investigating deviations, and completing validation protocols. The position requires strong math skills, critical thinking, attention to detail, and proficiency in MS Office. The candidate will also assist in training and guiding employees and coordinating shift activities. This is a second shift position requiring adherence to GMP and cleanroom standards, with the ability to lift 40 lbs and work in various environmental conditions.
Work Schedule
Second Shift (Afternoons)Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
Job Title: Lead Formulation Technician
***Second SHIFT***
At Thermo Fisher Scientific Inc., we are seeking an outstanding Upstream Processing Lead Technician to join our team in St. Louis, MO. As a world-class leader in the manufacturing of Commercial and Clinical Biologics, we are dedicated to making the world healthier, cleaner, and safer. In this role, you will have the opportunity to contribute to the production of life-saving therapies and play a vital role in our mission.
A day in the Life:
Carry out tasks related to manufacturing batch records, work instructions, and/or SOPs, ensuring meticulous execution and a proactive attitude towards achieving accuracy on the initial attempt. Assist in the process of reconciling batch records.
Complete all department functions, including maintaining the suite, supplies, equipment, logbooks, and data in accordance with site SOPs and policies.
Document all activities to meet cGMP requirements, ensuring daily record review, tasks, and databases are up to date.
Perform preventative maintenance and work notification tasks on time, as well as equipment testing and routine troubleshooting.
Coordinate and perform timely consumption of materials and ensure completion of quality documentation in appropriate systems.
Identify deviations, aid in investigations and root cause analysis, and provide input on major/critical deviations.
Complete validation protocols with minimal direction.
Schedule activities and coordinate the shift huddle in the absence of the supervisor, serving as a liaison with other groups within the manufacturing organization.
Participate in shift exchanges, meetings, and lean activities to facilitate area needs based on changes.
Job Responsibilities:
Monitor cell culture from 100mL to 5000L.
Conduct aseptic cell culture operations.
Operate production bioreactors of varying capacities, ranging from 50L to 5000L.
Conduct large-scale filtration or centrifugation.
Job Requirements:
Education:
Equivalent experience is acceptable, with a preference for candidates holding a HS Diploma/ GED or a Bachelor's degree.
Experience:
- 0 - 4 years relevant work experience required based on education.
Experience in cGMP environment preferred.
Knowledge, Skills, Abilities:
Knowledge of cGMP practices, aseptic techniques, or chemical concepts preferred.
Subject Matter Expert on upstream processing steps.
Strong math skills.
Critical thinking and problem-solving capabilities.
Attention to detail is essential.
Passionate about achieving objectives.
Efficient in MS Office.
Qualified to train and guide employees preferred.
Abilities:
Critical evaluation of processes, including foresight and thinking ahead.
Able to read, write, and communicate in English.
Able to understand and carry out instructions.
Reliable.
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.
Seeks and encourages feedback and responds to mentor.
Physical Requirements / Work Environment:
Willingness to wear a full gowning suit and adhere to clean room gowning requirements.
Able to lift a minimum of 25 lbs independently.
Ability to stand for 80% of the shift.
Join our team at Thermo Fisher Scientific Inc. and be part of a company that values integrity, intensity, innovation, and involvement. Apply today and #StartYourStory with us!
Benefits:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Apply today! http://jobs.thermofisher.com
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