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Upstream Manufacturing Associate III
Job in
Pennington, Mercer County, New Jersey, 08534, USA
Listed on 2026-10-17
Listing for:
Planet Pharma
Full Time
position Listed on 2026-10-17
Job specializations:
-
Manufacturing / Production
Pharmaceutical Manufacturing, Validation Engineer, Production QC/QA, Manufacturing & Industrial Operations
Job Description & How to Apply Below
30-40/hr
* depending on experience
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.
- 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.
- Perform and review manufacturing support testing utilizing:
- Cedex Cell Analyzer
- Blood Gas Analyzer (BGA)
- Osmometer
- Other process monitoring equipment
- 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.
- 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.
- Train, mentor, and develop Associate I and Associate II personnel.
- Provide technical coaching and floor-based leadership.
- Support qualification and onboarding programs.
- 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.
- 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.
- Experience supporting:
- Technology transfers
- Process validation
- Commercial manufacturing
- Regulatory inspections
- Continuous improvement initiatives
- 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.
Position Requirements
10+ Years
work experience
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