Sr. Process Engineer, MS&T

Job Summary

The Senior Process Engineer at Harrow will play a crucial role in the tech transfer of FDA-approved drug products to contract manufacturing organizations (CMOs). Reporting directly to the Sr. Director of Manufacturing Science & Technology (MS&T), the Senior Process Engineer will ensure the seamless transition of drug products from development to commercial production.

Core Responsibilities

• 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.

Qualifications & 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.

Position Type

• Remote

Travel

• Minimal travel to CMOs might be necessary.