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Work Schedule

12 hr shift/nights

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Location/Division Specific Information

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

Discover Impactful Work:

This candidate will be responsible for overseeing all activities of the teams responsible for cleaning and sanitizing the manufacturing facility, cleaning of primary, secondary, and ancillary equipment, and assembly of production related manufacturing tanks, vessels, and supply assemblies in support of the manufacture of Commercial and Clinical Biologics. This individual will be accountable for the Safety, Quality, Deliver, Cost, and Engagement metrics associated with the Production Support department and ensuring that all work performed in the department are following standard cGMP documented practices per the assigned shift. This individual will be responsible for following Current Good Manufacturing Practices (cGMPs).

A day in the Life:

+ 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 logbook review, tasks, and databases.

+ Forecast and resolve supply and raw material deficiencies. Identify and resolve scheduling conflicts with one week outlook.

+ Identify deviations, aid in investigations/root cause analysis, and provide input on major/critical deviations.

+ Represent manufacturing team at tier meetings.

+ Practices and promotes safe work habits and adheres to safety procedures and guidelines.

+ Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations.

+ Provides feedback on document revisions and/or document management including batch production records and manufacturing procedures.

+ Maintain safe and clean work environment by educating and directing personnel to ensure compliance with established policies and procedures.

+ Coordinates training with team either in class or on the floor, as needed.

+ Helps build cross-functional relationships and enhances relationships with team members.

+ Provides frequent feedback and coaching to others on ways to improve performance.

+ Complete production plan by scheduling and assigning personnel, prioritizing tasks, supervising progress, revising schedules, resolving problems, and reporting results.

+ Lead shift exchanges and daily huddles for team as required. Act as liaison with other groups within the manufacturing organization and a Subject Matter Expert on various techniques.

Keys** **to Success:

Education** **:

+ HS Diploma/ GED required,bachelor’s degree preferred

Experience** **:

+ 5 years relevant work experience required

+ 2+ years supervisory/leadership experience preferred (pharmaceutical industry preferred)

+ Experience in cGMP environment preferred

Knowledge, Skills, Abilities

Knowledge

+ Knowledge of cGMP practices, aseptic techniques, or chemical concepts- preferred

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

+ Ability to lift minimum of 25 lbs independently

+ Ability to stand, walk, reach, stoop, kneel and/ or crouch for 80% of the shift

Relocation assistance is NOT provided

Must be legally authorized to work in the United States without sponsorship, now or in the future.

Must be able to pass a comprehensive background check, which includes a drug screening.

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.