Lead Formulation Technician

RiseMe; St. Louis (MO); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

Healthcare benefits

Career development opportunities

Job summary

Thermo Fisher Scientific Inc. in St. Louis, MO is seeking an outstanding Lead Formulation Technician to join our Upstream Processing team. You will contribute to the production of life-saving biologics and ensure adherence to cGMP, safety, and quality standards.

The role involves managing batch records, equipment, and data in SOP-compliant systems, performing aseptic operations, operating bioreactors, and supporting investigations and deviations with a proactive, detail‑oriented mindset.

Qualifications

• Equivalent experience acceptable; preference for HS diploma/GED or Bachelor's degree.
• Strong problem-solving and analytical skills in a cGMP environment.
• Proficiency with MS Office and data documentation.
• Ability to work in a fast-paced, team-oriented manufacturing setting.

Responsibilities

• Monitor and document cell culture from 100 mL to 5000 L.
• Operate bioreactors from 50 L to 5000 L and perform large-scale filtration or centrifugation.
• Maintain batch records, equipment, logbooks, and data per SOPs and cGMP requirements.
• Identify deviations and assist in investigations and root-cause analysis.
• Coordinate shift activities and support lean initiatives.

Skills

Critical thinking

Problem solving

Strong math skills

Attention to detail

Able to read, write, and communicate

Education

HS Diploma/GED

Bachelor's degree

Tools

MS Office

Job description

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 ProcessingLeadTechnician 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 aBachelor'sdegree.

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 25lbs independently.
• Ability to stand for 80% of the shift.

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!