Senior Downstream Purification Lead - 3rd Shift

System One, Inc.; Pennington (NJ); On-site; USD 45,000 - 52,000; Full time

Benefits offered by this job

Health and welfare benefits

401(k) plan

Job summary

System One, Inc. is seeking a Manufacturing Associate III, Downstream Processing for the 3rd shift on-site in Pennnington, NJ. You will lead downstream operations, manage campaigns, ensure readiness of equipment and materials, and serve as the primary technical resource on the floor.

You will guide SOPs, MBRs, batch records, and documentation while supporting CAPAs, deviations, and process improvements in a GMP environment.

Qualifications

• Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, or Life Sciences with 5+ years of biopharma experience.
• Extensive hands-on experience with Protein A, polishing chromatography, and AKTA systems.
• Strong GMP knowledge and documentation practices; leadership abilities.

Responsibilities

• Lead daily downstream manufacturing operations and provide shop-floor technical support.
• Coordinate execution of manufacturing campaigns and purification schedules.
• Oversee chromatography skids, AKTA systems, BioSC and TFF platforms.

Skills

Downstream purification operations

AKTA chromatography

TFF platforms

Viral filtration

GMP compliance

Leadership

Troubleshooting

Education

Bachelor's degree in Biotechnology or Life Sciences

Tools

AKTA systems

TFF systems

BioSC

Protein A capture

Sterile filtration

Job description

System One, Inc. is seeking a Manufacturing Associate III, Downstream Processing for the 3rd shift on-site in Pennnington, NJ. You will lead downstream operations, manage campaigns, ensure readiness of equipment and materials, and serve as the primary technical resource on the floor.

You will guide SOPs, MBRs, batch records, and documentation while supporting CAPAs, deviations, and process improvements in a GMP environment.