Work Schedule
12 hr shift/days
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, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, 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 be responsible for the 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.
- Complete preventative maintenance and work notifications tasks on time. Perform equipment testing and routine trouble-shooting.
- Forecast and resolve supply and raw material deficiencies. Identify and resolve scheduling concerns with one week outlook.
- Supervise 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 techniques.
- Act as on the floor lead in absence of the supervisor.
- Participate in shift exchanges, 1-1’s, meetings, attend meetings to facilitate area needs based on changes, etc. (lean activities).
- Represent manufacturing team at tier meetings.
- Practices and promotes safe work habits and adheres to safety procedures and guidelines.
- Uses 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.
- 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.
Keys to Success:
Education:
- HS Diploma/ GED required, Bachelor's degree preferred
Experience:
- 2 - 6 years relevant work experience required based on education
- Experience in cGMP environment preferred
- Upstream (cell culture) single use technology biopharmaceutical manufacturing preferred
- Aseptic manufacturing preferred
Knowledge, Skills, Abilities
Knowledge
- Knowledge of cGMP practices, aseptic techniques, or chemical concepts- preferred
- Subject Matter Expert on upstream 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
- Qualified to train 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
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 an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
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.
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