Principal Researcher, Upstream Development

Description

We're looking for a Principal Researcher, Upstream Development, working in the Biotechnology/Medical Devices industry at 210 Welsh Pool Road, Exton, Pennsylvania, 19341, United States.

Responsibilities:

• Execute upstream small scale model development studies and generate qualification protocols, including data collection, analysis, and technical report writing.
• Generate characterization protocols and execute studies for proven acceptable range, including data collection, analysis, and technical report writing.
• Generate process performance qualification protocols for upstream commercial scale processes and coordinate process execution, including data collection, analysis, and technical report writing.
• Support process deviation by executing studies as appropriate.
• Support upstream process technology transfer to CMO as appropriate.
• Order supplies, manage samples, discard expired reagents, and perform housekeeping and other laboratory maintenance tasks to ensure laboratories are continuously maintained in a safe, orderly, and efficient condition.
• Participate in process improvement evaluation.
• Interact cross-functionally with Downstream Process Development, Operations, Facilities, R&D, Quality Assurance, Quality Control, QC Biochemistry, and other internal and external functions to support successful product development.