Senior Process Engineer, MS&T

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October 2

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Harrow (NASDAQ: HROW) is a growing leader in the ophthalmic healthcare market.

201 - 500 employees

💰 $100M Post-IPO Debt on 2023-03

📋 Description

• 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.

🎯 Requirements

• Bachelor's degree in pharmacy, chemistry, or pharmaceutical engineering with at least six years' pertinent and progressive experience or Master's degree with minimum of three years' experience. • Experience in Formulations, Process Development or Technical Services, with direct experience in formulation and process development of Sterile Products. • Strong understanding of aseptic manufacturing, aseptic filling and sterilization required.

🏖️ Benefits

• Minimal travel to CMOs might be necessary.