Manufacturing Associate II, Upstream Processing (2nd shift)

System One; Pennington (NJ); On-site; USD 36,000 - 44,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Paid time off

Job summary

System One is seeking an Upstream Manufacturing Associate II for the Pennington, NJ area. The role supports bioreactor operations, media prep, seed trains, and harvests in a 2nd shift 2pm-10pm schedule.

The position requires mammalian cell culture expertise, GMP knowledge, and 3–5 years of related biopharma experience (or 6+ years with HS diploma). Strong analytical and teamwork skills are essential for success.

Qualifications

• Requires strong mammalian cell culture and upstream processing knowledge.
• Experience operating bioreactors and related equipment.
• GMP manufacturing understanding with analytical/troubleshooting skills.
• Bachelor's degree or equivalent experience as noted above.

Responsibilities

• Independently execute upstream manufacturing operations in cGMP cleanroom.
• Prepare media and buffers; conduct cell culture expansion and seed train.
• Operate fed-batch and perfusion bioreactor systems and perform harvest.
• Monitor processes, review data, and troubleshoot equipment issues.
• Maintain GMP documentation and support deviations/audit readiness.
• Train Associate I personnel and contribute to continuous improvement.

Skills

Mammalian cell culture

Upstream processing

GMP manufacturing

Analytical & troubleshooting

Communication & teamwork

Education

Bachelor's degree in Biotechnology / Biochemistry / Chemical Engineering / Life Sciences

High School Diploma/GED with 6+ years of relevant experience

Tools

Bioreactors

Single-use bioreactor systems

Cedex Cell Analyzer

Blood Gas Analyzer

Osmometer

pH/Conductivity meters

Job description

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.