Upstream Manufacturing Associate I-III

Planet Pharma; Pennington (NJ); Presencial; USD 33.000 - 52.000; Jornada completa

Descripción de la vacante

Planet Pharma is seeking an Upstream Manufacturing Associate III (Lead) to provide technical leadership and coordinate upstream manufacturing activities in a cGMP environment. The role leads batch execution, troubleshooting, and cross-functional collaboration across QA, QC, MSAT, and supply chain.

The candidate will oversee cell culture activities, harvest and filtration, process monitoring, and continuous improvement initiatives to drive operational excellence.

Formación

• Bachelor’s degree or equivalent with relevant biopharmaceutical experience.
• Strong understanding of cGMP requirements and documentation practices.
• Experience in upstream bioprocessing and cell culture operations preferred.

Responsabilidades

• Lead daily upstream manufacturing operations on the shop floor.
• Coordinate production campaigns and manufacturing schedules.
• Ensure manufacturing readiness for batch execution.
• Provide technical coaching to Associate I/II personnel.

Conocimientos

Biological manufacturing

Cell culture processes

Documentation practices

Team collaboration

Educación

Bachelor’s degree in Biotechnology/biochemistry/chemical engineering

High School Diploma/GED with 4+ years biopharmaceutical experience

Herramientas

Cedex Cell Analyzer

Blood Gas Analyzer (BGA)

Osmometer

Descripción del empleo

Pay range: 24-38/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 0-2 years of relevant experience.
• High School Diploma/GED with 4+ years of relevant biopharmaceutical manufacturing experience may be considered.

Required Skills

• Basic understanding of biological manufacturing and cell culture processes.
• Ability to follow detailed instructions and procedures.
• Strong attention to detail and documentation practices.
• Effective communication and teamwork skills.
• Knowledge of cGMP requirements is preferred.

Preferred Skills

• Experience with:
• Cell culture operations
• Shake flask cultivation
• Bioreactor systems
• Buffer and media preparation
• Single-use technologies
• Aseptic processing

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.