Teams at Scientific Protein Laboratories

Develop, scale up, optimize, and transfer biopharmaceutical manufacturing processes from lab/pilot to commercial GMP production. Prepare PFDs, mass balances, protocols, SOPs, and validation activities (IQ/OQ/PQ). Support troubleshooting, CAPAs, equipment selection, technical reporting, training, and cross-functional project work while ensuring cGMP and regulatory compliance.

Supervise on-site Quality Assurance activities for cGMP API manufacturing, including inspections, batch record review, raw material release, investigations, deviations, change controls, CAPAs, product release decisions, audit support, and QA metrics reporting. Manage QA staff, training, procedures, and continuous improvement to maintain compliance with FDA/ICH/USDA/ISPE standards.

Execute and maintain quality systems for a cGMP biopharmaceutical site, including GMP training, review/approval of validation and qualification documents, managing investigations/deviations/CAPAs, change control, audit coordination/response, APR preparation, and continuous improvement projects.