Lead Formulation Technician

Work Schedule

Environmental Conditions

Job Description

Job Title: Downstream Processing Lead Technician IV

Location/Division Specific Information

St. Louis MO/ Drug Substance Division (Biologics)

Are you ready to take your career in manufacturing to the next level Thermo Fisher Scientific Inc. is currently seeking a highly skilled and motivated Downstream Processing Technician IV to join our world-class team in St. Louis. As a leading company in the scientific research industry we are dedicated to enabling our customers to make the world healthier cleaner and safer.

In this role you will have the opportunity to work with a team of exceptional professionals and play a vital role in the flawless execution of manufacturing batch records work instructions and SOPs. Your keen attention to detail and proactive approach will ensure that all tasks are completed right the first time. Additionally you will assist in maintaining the suite supplies equipment logbooks and data to strict cGMP standards contributing to the success of our manufacturing operations.

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. 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.
• Documentation of 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 1-1s 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 Bachelors 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
• Qualified to train other employees- preferred
• Qualified to train (preferred) and guide employees.

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
• Ability to lift minimum of 25 lbs independently
• Ability to stand for 80% of shift

Join Thermo Fisher Scientific and be part of our ambitious team that strives for excellence in everything we do. 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.

To apply please visit our career website at .

Thermo Fisher Scientific Inc. is an EEO/Affirmative Action Employer and provides equal employment opportunities to all employees and applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

If you require any accommodations during the application process due to a disability please contact us at 1-*. We are here to support you and ensure that you have an equal opportunity to succeed.

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