Upstream Manufacturing Associate II

Planet Pharma; Pennington (NJ); On-site; USD 34,000 - 48,000; Full time

Job summary

Planet Pharma in Pennington, NJ seeks an Upstream Manufacturing Associate II to independently execute upstream manufacturing operations in a cGMP cleanroom, leveraging expertise in mammalian cell culture, bioreactor operations, harvest processing, and in-process testing.

The role includes mentoring junior associates, supporting process improvements, and ensuring accurate GMP documentation while contributing to technology transfer and manufacturing readiness.

Qualifications

• Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 3–5 years of relevant biopharmaceutical manufacturing experience.
• High School Diploma/GED with 6+ years of relevant experience may be considered.
• 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; good communication and teamwork.

Responsibilities

• 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.
• Maintain aseptic operations and GMP-compliant documentation.

Skills

Cell culture

Bioreactor operations

GMP knowledge

Troubleshooting

Team collaboration

Education

Bachelor’s degree in Biotechnology/Life Sciences

High School Diploma + 6+ years experience

Tools

Cedex Cell Analyzer

Blood Gas Analyzer

Osmometer

pH meters

Conductivity meters

Job description

Pay range: 25-35/hr
depending on experience

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.

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.

Qualifications

Education & Experience

• Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 3-5 years of relevant biopharmaceutical manufacturing experience.
• High School Diploma/GED with 6+ years of relevant experience may be considered.

Required Skills

• 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.

Preferred Skills

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

Physical Requirements

• Ability to stand for extended periods.
• Ability to bend, reach, and lift up to 50 pounds.
• Ability to work in cleanroom environments while wearing required PPE.