Teams at Scientific Protein Laboratories, LLC

Develops, scales up, optimizes, and transfers biopharmaceutical manufacturing processes from lab/pilot to commercial GMP production. Prepares PFDs, mass balances, protocols, and SOPs; executes engineering batches; supports equipment qualification (IQ/OQ/PQ), troubleshooting, CAPAs, validation, and training. Collaborates cross-functionally and with CDMO clients while ensuring cGMP and regulatory compliance.

Supervise on-site QA operations including inspection of manufacturing/testing, batch record review, deviation management, CAPAs, audits, cGMP compliance, staff scheduling, training, and shift handoffs to ensure timely, compliant quality decisions.

Supervise on-site QA activities for cGMP API manufacturing including raw material inspection/release, batch record review, investigations, deviations, change controls, CAPAs, product release, audit support, and continuous improvement of quality systems. Manage QA staff, training, metrics, and regulatory compliance.