Process Development Associate

Downstream Pilot Plant Associate

Department: Manufacturing / Technical Operations

Position Summary

The Downstream Pilot Plant Associate plays a critical role in supporting the on-time delivery of high-quality gene therapy products. This position is responsible for executing downstream purification processes, maintaining GLP/GDP-compliant documentation, operating bioprocessing equipment, and contributing to continuous improvement and process support activities within a pilot-scale and production environment.

Key Responsibilities

• Execute downstream purification operations including chromatography, ultrafiltration, tangential flow filtration (TFF), ultracentrifugation, and depth filtration at pilot and production scales.
• Operate and maintain standard bioprocessing equipment such as chromatography systems, TFF units, and ultracentrifuges.
• Adhere to cGMP and GDP standards in all manufacturing activities.
• Prepare, review, and maintain batch records, SOPs, logbooks, raw material specs, campaign reports, and technology transfer documentation.
• Collaborate cross-functionally to support manufacturing investigations, root cause analysis, and process troubleshooting.
• Ensure facility readiness, compliance with internal SOPs, and support regulatory inspections.
• Utilize Quality Systems and ERP platforms to document and track manufacturing activities.
• Contribute to process improvements through change control and operational excellence initiatives.
• Serve as a subject matter resource for assigned processes and may supervise on-floor activities.
• Maintain a safe, compliant working environment and complete all required training.

Qualifications

• B.S. in Biology or a related discipline.
• 4–6 years of experience in process development or manufacturing support within bioprocessing.
• Hands-on experience with chromatography, ultrafiltration, depth filtration, and related downstream technologies.
• Strong understanding of cGMP and GDP requirements.
• Experience supporting manufacturing investigations in biologics is preferred.
• Familiarity with Quality Systems and ERP platforms.
• Strong technical writing, communication, and team collaboration skills.