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 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.

Supervise daily cGMP API manufacturing shift operations, ensuring safety, quality, and on-time production. Oversee personnel, review batch records and documentation for ALCOA+ compliance, escalate deviations, support investigations and audits, coordinate with cross-functional teams, and lead continuous improvement and troubleshooting efforts.