Harrowhealth1mo ago

Sr. Process Engineer, MS&T

RemoteRemotesenior

EngineeringManufacturing & Production

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Quick Summary

Overview

Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going.

Technical Tools

EngineeringManufacturing & Production

Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going. It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in. If you want to call Harrow your home and genuinely want to be part of a family and something big, then we encourage you to click this link and get to know us.

Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an incredible entrepreneurial company – where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow’s values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world – providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need. We encourage you to learn more about Harrow and its unique culture to see if you’re the right person to help contribute as we build a truly exceptional company, one we are all so proud of!

Harrow’s ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:

An expanding Retina Portfolio including IHEEZO^®, TRIESENCE^®, BYOOVIZ^TM, and OPUVIZ^TM
A broad Dry Eye Disease product line, led by VEVYE^® and bolstered by well-known adjacent ocular surface disease products such as FLAREX^® and FRESHKOTE^®
A peri-operative Surgical product line, led by TRIESENCE^®, and BYQLOVI^TM
A Rare and Specialty product line, which includes various high-need and utility products such as ILEVRO^®, NATACYN^®, and VERKAZIA^®
A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01

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.

Responsibilities

~2 min read

→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.
→Serve as the primary technical lead for tech transfer workstreams, specifically managing the scale-up and validation of sterile ophthalmic formulations and injectable delivery systems.

Requirements

~1 min read

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 hands-on experience in the technology transfer of Ophthalmic or Injectable products.
Strong understanding of aseptic manufacturing, aseptic filling, and sterilization processes specific to small-molecule injectables or ophthalmic suspensions/solutions.