Teams at Repligen Corporation

Support quality across NPI, manufacturing transfer, and commercial operations by applying design controls, validation, and risk management. Own FMEA, design/process verification, IQ/OQ/PQ reviews, test method validation, change control, complaint investigations, nonconformance resolution, and continuous improvement using Lean/Six Sigma to ensure compliant, reliable product launches and manufacturing performance.

Lead IT-business alignment for Commercial functions, driving strategy, SAP/CRM/PIM system optimization, AI/automation and analytics initiatives, regulatory (GMP) compliance, enterprise integrations, process improvements, and stakeholder engagement to deliver measurable commercial outcomes.

Lead and mentor a multidisciplinary process and manufacturing engineering team to drive safety, quality, validation, process optimization, technology transfers, and capital projects. Support new product introductions, regulatory compliance (ISO/GMP), operational excellence (Lean/Six Sigma), and cross-functional collaboration to expand capacity and improve yield, productivity, and cost performance.