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Harrow · 3 months ago

Sr. Process Engineer, MS&T

United States

Full-time

Remote

Mid, Senior Level

3+ years exp

Harrow is a leading North American ophthalmic-focused pharmaceutical company that values innovation and patient access to affordable medicines. The Senior Process Engineer will be responsible for leading the technology transfer of FDA-approved drug products to contract manufacturing organizations, ensuring a seamless transition from development to commercial production.

BiotechnologyHealth CareMedical

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

Qualification

Process DevelopmentAseptic ManufacturingTechnical DocumentationFormulationsPharmaceutical EngineeringTroubleshootingCollaborationTechnical Leadership

Required

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