Upstream Manufacturing Associate III

Planet Pharma; Pennington (NJ); On-site; USD 41,000 - 55,000; Full time

Benefits offered by this job

Leadership development

Job summary

Planet Pharma is seeking an Upstream Manufacturing Associate III (Lead) to provide technical leadership and operational coordination for upstream manufacturing in a cGMP environment. You will lead batch execution, troubleshoot complex issues, and coordinate cross-functional teams to ensure readiness and continuous improvement.

The role requires 5+ years in biopharmaceutical manufacturing, strong mammalian cell culture expertise, and hands-on operation with fed-batch and perfusion bioreactor

Qualifications

• Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or related discipline.
• 5+ years of relevant biopharmaceutical manufacturing experience.
• Experience in leadership, lead operator, or project coordination roles preferred.
• Strong GMP knowledge and manufacturing documentation experience.

Responsibilities

• Lead daily upstream manufacturing operations and provide shop-floor technical support.
• Coordinate production campaigns and manufacturing schedules.
• Ensure manufacturing readiness for batch execution.
• Serve as the primary technical resource during manufacturing operations.
• Oversee cell culture expansion, harvest, and filtration steps.
• Monitor process parameters and implement corrective actions.
• Troubleshoot process and equipment issues to maintain operations.
• Lead documentation updates: SOPs, MBRs, forms and templates.
• Support deviations, CAPAs, and change controls, and audits.
• Coordinate with QA, QC, MSAT, and other functions; drive improvements.
• Coach and develop Associate I/II personnel and onboarding.

Skills

Mammalian cell culture

Upstream operations

Fed-batch bioreactors

Perfusion bioreactors

Cedex Cell Analyzer

Blood Gas Analyzer

Osmometers

GMP documentation

Leadership

Troubleshooting

Education

Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline

Job description

Pay range

30-40/hr
*depending on experience

Position Overview

The Upstream Manufacturing Associate III (Lead) provides technical leadership and operational coordination for upstream manufacturing activities within a cGMP environment. This role is responsible for leading batch execution, troubleshooting complex process issues, coordinating cross-functional teams, supporting manufacturing readiness, and driving operational excellence initiatives.

Key Responsibilities

Manufacturing Leadership

• Lead daily upstream manufacturing operations and provide shop-floor technical support.
• Coordinate execution of production campaigns and manufacturing schedules.
• Ensure manufacturing readiness for batch execution.
• Serve as the primary technical resource during manufacturing operations.

Upstream Processing

• Lead cell culture activities including vial thaw, seed train expansion, fed-batch and perfusion bioreactor operations.
• Oversee harvest and filtration operations.
• Monitor critical process parameters and implement corrective actions when required.
• Troubleshoot process and equipment issues to ensure uninterrupted operations.

In-Process Testing

• Perform and review manufacturing support testing utilizing:
  • Cedex Cell Analyzer
  • Blood Gas Analyzer (BGA)
  • Osmometer
  • Other process monitoring equipment

Documentation & Compliance

• Lead preparation and revision of:
  • Standard Operating Procedures (SOPs)
  • Master Batch Records (MBRs)
  • Manufacturing forms and templates
• Support deviation investigations, CAPAs, and change controls.
• Ensure ongoing inspection readiness and GMP compliance.
• Participate directly in regulatory and client audits.

Cross-Functional Coordination

• Coordinate activities between Manufacturing, QA, QC, MSAT, Warehouse, Facilities, and Supply Chain teams.
• Support process validation, technology transfer, and commercial manufacturing initiatives.
• Drive continuous improvement and operational excellence projects.

Coaching & Development

• Train, mentor, and develop Associate I and Associate II personnel.
• Provide technical coaching and floor-based leadership.
• Support qualification and onboarding programs.

Qualifications

Education & Experience

• Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 5+ years of relevant biopharmaceutical manufacturing experience.
• Previous leadership, lead operator, or project coordination experience preferred.

Required Skills

• Advanced expertise in mammalian cell culture and upstream operations.
• Extensive experience with fed-batch and perfusion bioreactor systems.
• Hands-on experience with Cedex, BGA, Osmometers, and related analytical equipment.
• Strong understanding of GMP regulations and manufacturing documentation systems.
• Proven leadership and decision‑making abilities.
• Excellent troubleshooting and problem‑solving skills.

Preferred Skills

• Experience supporting:
  • Technology transfers
  • Process validation
  • Commercial manufacturing
  • Regulatory inspections
  • Continuous improvement initiatives

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.