Work Schedule

12 hr shift/days

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.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

Location/Division Specific Information

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

Discover Impactful Work:

The candidate will help performance of operations in support of the manufacture of Commercial and Clinical Biologics. They will follow Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to Upstream (cell culture). These functions may include but are not limited to activities such as conducting aseptic cell culture operations and conducting large scale filtration or centrifugation.

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.

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.

Manage a team of skilled technicians as they conduct aseptic large scale cell culture operations.

Keys to Success:

Education:

HS Diploma/ GED required, Bachelor's degree preferred

Experience:

5 - 9 years relevant work experience required based on education

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 for 80% of 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 a company culture that stands for integrity, intensity, involvement, and innovation!

Apply today! http://jobs.thermofisher.com