CELL CULTURE, SR. TECHNICIAN

Duties

• Focused on execution of cGMP manufacturing activities required to deliver the production plan reliably and compliantly.
• Follow cGMP procedures to support manufacturing execution and automated recipes
• Media preparation & transfers / filtration
• Cell culture sampling, monitoring & transferring
• Harvest operations
• Equipment & process troubleshooting
• Deviation identification, reporting
• cGMP procedure development and optimization
• Requesting, staging, and verifying materials for production activities
• Completing batch documentation and reviewing records for accuracy
• Supporting routine cleanroom operations, equipment sanitization, and environmental monitoring
• Cleaning of the facility
• Collection of samples for environmental monitoring
• Removal of process waste
• Operation of Distributed Computer System (DSC)
• Operation of equipment’s such as Clean-in-Place (CIP), Steam-in-Place (SIP) skid, Caustic skid, autoclave, part washer, filter integrity tester, biowelders, etc.

Skills

• Evidence of good verbal and written communication
• Ability to work in fast paced dynamic environment with competing priorities
• Demonstrated ability to collaborate within and between diverse groups
• Proactive identification and implementation of continuous improvement opportunities
• Aptitude for learning moderately complex technical systems
• Able to receive and incorporate feedback – passion for ongoing professional development a plus

Requirements

• Must be able to stand for long periods, up to 8 to 10 hours/day
• Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently
• Must be able to work scheduled 40 hours with the ability to work overtime as needed
• Familiarity with computer-based systems. Word, Excel, and PowerPoint a must
• Upstream manufacturing
• Use of single use bioreactor systems
• Willing to work any shift

Qualifications

• At least 1 year of relative experience required
• High school education or GED required
• AS/BS/BA in science related field, biopharmaceutical or equivalent technical experience preferred