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
***DAY SHIFT***
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 propagation of mammalian cell culture, conducting aseptic cell culture operations, execution of large scare production bioreactors (50L - 2000L) 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.
Applies manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations.
Assists with 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.
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
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!
