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.
Who is Harrow?
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®, BYOOVIZTM, and OPUVIZTM
- 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 BYQLOVITM
- 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
Job Summary
The Manager of R&D and Tech Services will be responsible for leading and managing day-to-day R&D and Validation functions at our ImprimisRx 503B outsourcing facility, providing leadership, guidance, and hands-on direction across various activities within the department, including personnel, practices, and processes.
Core Responsibilities
- Responsible for leading R&D team for end-to-end activities from development of lead formulation and process to support manufacturing and launch of new products.
- Designing experiments in the laboratories, pilot plants, or manufacturing sites to identify the critical quality attributes of the process and establish appropriate process control.
- Develop and implement validation strategies for equipment, processes, cleaning, and systems in compliance with FDA and other regulatory guidelines.
- Provide leadership to the validation team for activities including but not limited to process validation, cleaning validation, equipment validation, and computer systems validation.
- Establish new manufacturing processes and/or refine existing ones to optimize processes and ensure quality, using statistical tools and proven scientific methods.
- Identify opportunities to optimize sterile/aseptic processes, reduce costs, and enhance quality across R&D and validation. Implement best practices and lead initiatives to drive continuous improvement efforts.
- Foster collaboration and technical/scientific communication with internal departments such as Quality Assurance, Manufacturing, and Supply Chain to achieve project goals and timelines related to R&D and Validation and improvement of product quality.
- Review of technical reports and specifications, and maintaining appropriate records for product and process development projects to ensure smooth process technology transfer.
- Troubleshooting and resolving manufacturing process problems—determining root cause and corrective actions using strong scientific reasoning.
- Developing process documentation and training materials to support the standardized processes and product launches.
- Effectively work with cross-functional teams to streamline development, validation, scale up, and launch activities.
- Perform review and approval of method validation and method transfer protocols and reports.
- Monitor the progression of development through each phase across all projects.
- Supervise the tech transfer of all products from R&D to manufacturing for new and existing products.
- Candidate must coordinate research and development analytical activities as required.
- Provide mentorship to the staff to enhance their personal and professional growth.
- Provide adequate supervision of personnel and guidance for the team's professional development.
Qualifications & Requirements
- MS degree in Chemistry, Pharmaceutical Sciences. Ph.D. degree a plus.
- Must have eight to ten years of industrial experience in formulation, process development, and validation. Experience in ophthalmic dosage preferred.
- Strong technical and scientific reasoning, tech transfer skills, and experience working alongside a manufacturing facility.
- Experience working with contract research laboratories in a fast-paced environment.
- Proven problem-solving, troubleshooting, and critical thinking skills.
- Practical interpersonal skills with solid communication skills, both verbal and in writing.
- Strong quantitative skills, proven attention to detail, and practical organizational skills.
- Maintains broad knowledge of scientific principles and theories and possesses an intellectual mastery of one or more scientific areas.
- Advanced knowledge and demonstrated ability to work with / recommend various laboratory equipment/tools.
- Able to work as part of and lead multiple teams.
- Exhibits leadership skills.
- Sees broader picture, impact on multiple programs, teams, and departments.
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
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