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Process Engineer

Leadstack Inc

Research Triangle Park, NC

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JOB DETAILS
SKILLS
Cell Cultures, Chromatography, Data Collection, Data Quality, Documentation, GLP (Good Laboratory Practices), Gene Therapy, Identify Issues, Laboratory Management, Laboratory Operations, Maintain Compliance, Manufacturing, Manufacturing Operations, Operational Support, Operations, Organizational Skills, Pre-Clinical, Procedure Development, Process Development, Process Engineering, Research Laboratory, Root Cause Analysis, Safety Process, Safety/Work Safety, Standard Operating Procedures (SOP), Time Management, Traceability
LOCATION
Research Triangle Park, NC
POSTED
30+ days ago
Process Engineer/Research Associate to provide hands-on laboratory and manufacturing support of AAV (rAAV) vector research and late-stage clinical gene therapy programs.
This role is execution-focused, supporting upstream and downstream manufacturing operations, routine experiments, and process development studies working in close coordination with manufacturing and MSAT staff.
The contractor will contribute to the timely completion of manufacturing and laboratory studies, data collection, and manufacturing readiness ensuring alignment with existing protocols to support early-stage gene therapy programs, technology development, and internal research priorities.
This is a laboratory-based contract role intended to support day-to-day manufacturing and experimental execution working closely with pre-clinical manufacturing and MSAT scientists.
Key Responsibilities:
Execute routine and defined rAAV manufacturing and laboratory activities for research and GLP-grade studies following established protocols and batch records.
Perform hands-on upstream and downstream operations, including:
Cell culture and maintenance
Vector production in shake flasks, WAVE bioreactors, and/or stirred-tank bioreactors
Centrifugation, filtration, chromatography, and related purification steps
Support process development and experimental studies, including process characterization and robustness testing, at small and pilot-scale by executing assigned experiments and manufacturing runs according to approved protocols, batch records, and study plans, ensuring accurate data generation and traceability.
Maintain clear, real time and accurate documentation of laboratory activities, experimental results, and manufacturing data in paper or electronic systems in accordance with department procedures to ensure compliance and data integrity..
Assist with batch record completion, data compilation, and data review.
Communicate experimental progress, observations, and results to project stakeholders in a clear and timely manner.
Support manufacturing investigations and troubleshooting activities, including execution of confirmatory experiments and data collection to inform root-cause analysis.
Contribute to technical protocols, experimental reports, and summary presentations describing executed work and generated data, as needed.
Support daily laboratory operations, including:
Equipment setup, operation, and routine maintenance
Coordination and execution of laboratory activities
Maintaining a clean, organized, and inspection-ready lab environment
Ensuring materials, consumables, and reagents are available for assigned experiments in coordination with lab management and solution prep teams.
Follow established safety procedures, SOPs, and documentation practices at all times.
Adhere to all safety, quality, and data integrity requirements during laboratory and manufacturing-support activities.

About the Company

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Leadstack Inc