What are the responsibilities and job description for the Process Development Associate position at Meet Life Sciences?
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.