Lead Formulation Technician

Able to lift 40 lbs. without assistance

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
• Laboratory Setting
• Loud Noises (Equipment/Machinery)
• Office
• Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
• Strong Odors (chemical, lubricants, biological products etc.)

Job Title

Work Schedule

Second Shift (Afternoons)

Location/Division Specific Information

St. Louis, MO/ Drug Substance Division (Biologics)

A Day in the Life

• 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.
• Absorb and assist with batch record reconciliation.
• Able to complete all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies.
• Document all activities to meet cGMP requirements.
• Daily record review, tasks, and databases.
• Complete preventative maintenance and work notifications tasks on time.
• Perform equipment testing and routine trouble-shooting.
• Oversee and 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.
• Complete validation protocols with minimal supervision or direction.
• Schedule activities and coordinate the shift huddle in absence of the supervisor.
• Act as liaison with other groups within the manufacturing organization and a Subject Matter Expert on a variety of downstream processing steps techniques.
• Participate in shift exchanges, 1-1’s, meetings, attend meetings as necessary to facilitate area needs based on changes, etc. (lean activities).
• Practices and promotes safe work habits and adheres to safety procedures and guidelines.
• Provides feedback on document revisions and/or document management including batch production records and manufacturing procedures.

Keys to Success

• Education: Required: High school diploma or equivalent Preferred: Associates Degree w/ +2 years of relevant years of experience or Bachelor's degree
• Experience: Required: Minimum of 4 years experience in a manufacturing, operations, production, lab setting or related field Preferred: Experience in a cGMP environment
• Knowledge, Skills, Abilities: Knowledge: Knowledge of cGMP practices, aseptic techniques, or chemical concepts - preferred Subject Matter Expert on downstream processing steps
• Skills: Strong math skills Critical thinking and problem-solving capabilities Detail Oriented Results Driven Efficient in MS Office
• 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 welcomes feedback and responds to coaching.

Physical Requirements / Work Environment

• 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.)
• Able to adhere to clean room gowning requirements, including wearing Tyvek, Nitrile, and/or Latex gloves
• Able to lift minimum of 25 lbs independently
• Able to stand for 80% of shift

Equal Opportunity Employer

We are an equal opportunity employer, committed to fostering an inclusive and diverse workforce. We value the unique perspectives and contributions of all individuals and actively encourage candidates from all backgrounds to apply.

Application Instructions

To apply, please visit our career website at http://jobs.thermofisher.com.