Harrow

Engineer

• Lead technology transfer of branded ophthalmic products to cGMP Contract Manufacturing Organizations (CMOs).
• Serve as the primary point of contact with CMOs and external partners for all technology transfer activities.
• Prepare, review, and approve technical documentation—including protocols, reports, and product/process validation packages (IQ, OQ, PQ)—to ensure accuracy and completeness.
• Provide technical leadership in CMO project transfer meetings, offering guidance and managing deliverables.
• Collaborate cross-functionally with MS&T, Quality Assurance, Quality Control, Supply Chain, and other departments to ensure seamless transfer and maintenance of processes at CMOs.
• Compile and analyze process data, communicate project status, identify trends, and meet internal and external reporting requirements.
• Support CMO selection by assessing manufacturing capabilities and driving initiatives to reduce and improve process variability.
• Troubleshoot and resolve manufacturing challenges by identifying root causes and implementing effective corrective actions.
• Provide process engineering recommendations to ensure transferred products are robust, compliant, and aligned with current manufacturing technologies.
• Partner with manufacturing teams to ensure compliance and product quality throughout the entire engineering and commercial operations process.
• Oversee product transitions into CMOs, ensuring readiness for production, quality assurance, and regulatory compliance.
• Serve as Subject Matter Expert (SME) for critical processes and provide technical leadership across the organization.

Senior Process Engineer, MS&T