Manufacturing Associate II, Upstream Processing (2nd shift)

Job Title: Manufacturing Associate II, Upstream Operations 2nd shift
Location: Pennington, NJ (Greater Hopewell NJ area)
Shift: 2nd Shift 2pm-10pm M-F
Salary (Pay) Range: $26.00/hour to $32.00/hour, plus $2 shift Differential for 2nd shift
Industry: Global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and Biosimilar Developer


Position Overview

The Upstream Manufacturing Associate II independently executes upstream manufacturing operations in a cGMP cleanroom environment. This role requires technical expertise in mammalian cell culture, bioreactor operations, harvest processing, and in-process testing while serving as a mentor to junior associates and supporting process improvements.

Must Haves

• Strong understanding of mammalian cell culture and upstream processing.
• Experience operating bioreactors and associated equipment.
• Knowledge of GMP manufacturing requirements.
• Strong analytical and troubleshooting skills.
• Effective communication and team collaboration abilities.
• Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline and
  • 3-5 years of relevant biopharmaceutical manufacturing experience.
• or High School Diploma/GED with 6+ years of relevant experience may be considered.

Preferred Skills

• Single-use bioreactor systems
• Perfusion technologies
• Cell culture analytics
• Process troubleshooting
• Technology transfer activities

Key Responsibilities

• Upstream Manufacturing Operations
• Independently execute media and buffer preparation activities.
• Perform cell culture expansion, vial thaw, seed train operations, and production-scale bioreactor processing.
• Operate and monitor fed-batch and perfusion bioreactor systems.
• Execute harvest, filtration, and process transfer operations.
• Troubleshoot manufacturing and equipment issues within established procedures.
• In-Process Monitoring
• Perform routine process monitoring and data review.
• Operate analytical equipment including:
• Cedex Cell Analyzer
• Blood Gas Analyzer (BGA)
• Osmometer
• pH and conductivity meters
• Aseptic Processing & Compliance
• Perform aseptic operations in classified environments.
• Maintain GMP-compliant documentation.
• Participate in deviation investigations and root cause assessments.
• Support audit preparation and inspection activities.
• Training & Continuous Improvement
• Train and mentor Associate I personnel.
• Assist with SOP revisions and manufacturing documentation updates.
• Participate in process improvement and operational excellence initiatives.
• Support technology transfer and manufacturing readiness activities.

Physical Requirements

• Ability to stand for extended periods.
• Ability to bend, reach, and lift up to 25 pounds.
• Ability to work in cleanroom environments while wearing required PPE.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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