Lead Downstream Manufacturing Scientist - Biologics

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

Job summary

Planet Pharma is seeking a Downstream Manufacturing Associate III (Lead) to provide technical leadership for downstream purification operations in a cGMP environment, coordinating campaigns and batch execution.

This role leads purification steps, ensures readiness, troubleshoots issues, and collaborates with QA, QC, MSAT, Validation, Engineering, Facilities, and Supply Chain to drive manufacturing excellence.

Qualifications

• Bachelor's degree in biotechnology or related field.
• 5+ years of biopharmaceutical manufacturing experience.
• Previous lead operator, project coordination, or team leadership experience preferred.

Responsibilities

• Lead daily downstream manufacturing operations and provide shop-floor technical support.
• Coordinate execution of manufacturing campaigns and purification schedules.
• Ensure manufacturing readiness, equipment availability, and material preparedness for batch execution.
• Serve as the primary technical resource during downstream manufacturing operations.
• Provide real-time decision support during process execution and batch recovery activities.
• Lead purification operations including Protein A capture, viral inactivation, ion exchange chromatography, UF/DF, viral filtration, and final bulk drug substance processing.
• Oversee operation and performance of chromatography skids, AKTA systems, BioSC, TFF systems, and filtration equipment.
• Monitor critical process parameters and ensure adherence to process specifications.
• Troubleshoot process and equipment issues to maintain operational continuity.
• Support implementation of process improvements and manufacturing optimization efforts.
• Lead preparation and revision of SOPs, MBRS, manufacturing forms and logs, and equipment/process documentation.

Skills

Downstream purification leadership

AKTA systems operation

Problem solving

Cross-functional coordination

Leadership

Education

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

Tools

AKTA chromatography systems

TFF platforms

Protein A chromatography

Viral filtration equipment

Job description

Planet Pharma is seeking a Downstream Manufacturing Associate III (Lead) to provide technical leadership for downstream purification operations in a cGMP environment, coordinating campaigns and batch execution.

This role leads purification steps, ensures readiness, troubleshoots issues, and collaborates with QA, QC, MSAT, Validation, Engineering, Facilities, and Supply Chain to drive manufacturing excellence.