Perform purification method development, optimization, and scale up activities using methods such as, Protein A Purification, Cation Exchange Purification, Anion Exchange Purification, Ultrafiltration / Diafiltration.
Process, analyze, and validate data generated by purification runs.
Develop, optimize, and scale downstream purification processes for biologics, vaccines, cell therapies, and other biopharmaceutical products using chromatography, filtration, ultrafiltration/diafiltration (UF/DF), and related purification technologies.
Design and execute process development, characterization, and scalability studies to improve product recovery, purity, yield, and overall manufacturing performance.
Analyze experimental data to identify critical process parameters, support process understanding, and contribute to technology transfer, process validation, and commercial manufacturing activities
Document laboratory work in real time using electronic lab notebooks and maintain accurate records in accordance with GMP, GLP, and GDP expectations.
Author and review methods and technical reports, study protocols, standard operating procedures (SOPs), and validation documentation while maintaining compliance with applicable quality and regulatory requirements.
Use laboratory software and systems, including Unicorn and electronic lab notebooks, to capture, manage, and support purification activities.
Proficient with operating AKTA Avant Systems including troubleshooting problems, overseeing preventative maintenance of the instrument, and scheduling emergent vendor repairs.
Responsible for planning and organizing materials for executing purification experiments including but not limited to buffer ordering, column packing, setting up and organizing necessary materials
Lead technology transfer and scale-up efforts, preparing clear transfer packages and supporting manufacturing start-ups.
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