Work Schedule
12 hr shift/days

Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Shift: 12hrs Day or Night Shift on rotating 2/2/3 schedule

Pay: $27+/hr

Discover Impactful Work:

The candidate will help 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.

• Execution of manufacturing batch records, work instructions and/or SOPs, with focus on proactive 'right the first time' executions. Assist with batch record reconciliation
• Assist in 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. Complete document reviews and revisions. Daily record review, tasks, and databases. Participate/Lead in shift exchanges, 1-1's, meetings, attend meetings as needed to facilitate area needs based on changes, etc. (lean activities).
• Support a quality investigation by answering questions and making suggestions for improvement.
• Practices and promotes safe work habits and adheres to safety procedures and guidelines.
• Critical evaluation of processes, including foresight and thinking ahead.
• Ensure tasks are performed with a method of prioritization - interpret production schedules and complete tasks accordingly.

• HS Diploma or equivalent required

• Required: Minimum of 2 years of work experience in manufacturing, operation, production, lab setting or related field
• Preferred: Experience in a cGMP environment
• Knowledge of cGMP practices, aseptic techniques, or chemical concepts- preferred
• Subject Matter Expert on upstream processing steps- preferred
• Critical thinking and problem solving
• Strong math skills
• MS Office
• Able to demonstrate practical knowledge with successful outcomes
• Able to recognize problems developing, not just occurring
• Able to read, write, and communicate in English
• Able to understand and carry out instructions

• 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 meet 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