Work Location: Mercer County, New Jersey

Summary:

The Senior Technician Cell Culture is responsible for executing cGMP manufacturing activities, supporting cell culture operations, and ensuring compliance with established procedures. This role involves hands-on work in a dynamic environment, focusing on production reliability, process optimization, and maintaining cleanroom standards.

Responsibilities:

• Execute cGMP manufacturing activities, including following established procedures and supporting automated recipes for cell culture production.
• Prepare and transfer media, perform filtration, and conduct cell culture sampling, monitoring, and transfers as required.
• Carry out harvest operations and troubleshoot equipment and process issues to ensure smooth production flow.
• Identify, report, and support resolution of deviations, and contribute to the development and optimization of cGMP procedures.
• Request, stage, and verify materials for production, complete batch documentation, and review records for accuracy and compliance.
• Support routine cleanroom operations, including equipment sanitization, environmental monitoring, and facility cleaning.
• Collect samples for environmental monitoring, remove process waste, and operate various equipment such as CIP, SIP skid, autoclave, and biowelders.
• Utilize distributed computer systems and standard software (Word, Excel, PowerPoint) to support manufacturing and documentation activities.

Qualifications:

• High school diploma or GED required.
• At least 1 year of relevant experience required.
• AS/BS/BA in a science-related field, biopharmaceutical, or equivalent technical experience preferred.
• Strong verbal and written communication skills.
• Ability to work in a fast-paced, dynamic environment with competing priorities.
• Demonstrated collaboration skills within and between diverse groups.
• Proactive in identifying and implementing continuous improvement opportunities.
• Aptitude for learning moderately complex technical systems.
• Receptive to feedback and committed to ongoing professional development.
• Physical ability to stand for long periods (8-10 hours/day), reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.
• Ability to work scheduled 40 hours per week with overtime as needed.
• Familiarity with computer-based systems; proficiency in Word, Excel, and PowerPoint required.
• Experience with upstream manufacturing and single-use bioreactor systems preferred.
• Willingness to work any shift as required by production needs.

Published Category: Manufacturing & Technical Operations