Teams at Syner-G

Lead integrated Verification and Commissioning & Qualification (C&Q) programs for large GMP capital projects using ASTM E2500 principles. Manage scope, budget, schedule, resources, risks, and cross-functional teams through design, construction, startup, verification, system turnover, and operational handover. Oversee development and execution of verification plans, testing, documentation, and regulatory compliance while mentoring teams and supporting audits and client interactions.

Lead design, integration, commissioning, qualification, and startup of lyophilization systems for sterile vial manufacturing. Serve as technical lead for lyophilizer–aseptic filling integration, automation/SCADA/PLC interfaces, vendor coordination, IQ/OQ/PQ execution, troubleshooting, risk mitigation, and operational readiness while ensuring GMP/Annex 1 compliance and mentoring junior engineers.

Lead regulatory strategy for clients across drug development stages, author and submit NDA/BLA/IND materials, manage FDA interactions (Type A/B/C), coordinate global submissions, evaluate manufacturing/quality impacts, mentor staff, and provide regulatory advice and industry thought leadership.