2nd Shift Compounder

Harrowhealth; Ledgewood (NJ); On-site; USD 48,000 - 72,000; Full time

Job summary

Harrowhealth in New Jersey seeks a Compounder to perform cGMP manufacturing of sterile dosage forms for commercial production. You will work hands-on in ISO7/ISO5 areas with various production equipment, weighing materials, manufacturing batches, sterilizing products, submitting samples and performing filling operations.

The role emphasizes documentation accuracy, real-time batch record review, and strict GMP compliance.

Qualifications

• Fluent in English both written and spoken
• Ability to gown into aseptic manufacturing areas
• Strong organization and time-management skills
• Technical knowledge to operate and troubleshoot processing equipment
• Proficient in Microsoft Office (Excel, Outlook, Word)
• Sensitivity to handling confidential information
• Flexible to work 1st or 2nd shift including holidays and overtime

Responsibilities

• Contributes to cGMP manufacturing of sterile dosage forms for commercial use
• Operates equipment and performs weighing, batch manufacturing, sterilization, sampling and filling in ISO7/ISO5 environments
• Reviews Batch records and logbooks in real time, ensuring accuracy and compliance
• Follows Safety Policies, GMP and SOPs, reports hazards or deviations promptly
• Obtains equipment and raw materials and supports production planning

Job description

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®, BYOOVIZ™, and OPUVIZ™
• 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™
• 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 hours for this position are 3pm - 1:30am

Job Summary

The compounder will be responsible for conducting cGMP manufacturing of sterile pharmaceutical dosage forms for commercial manufacturing. Under the direction of the Production Supervisor, the compounder will work hands on, under ISO7 and ISO5 area, with a variety of manufacturing production equipment and technologies. Daily responsibilities vary and include production equipment set up, weighing of materials, manufacturing of batches, sterilization of product, submitting samples,performing filling operations under ISO7 environment.

Core Responsibilities

• Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). Knowledge of current Good Manufacturing Practices (GXP) guidelines.
• Reports any accidents, incidents and injuries or illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace.
• Prepares for production run by reviewing the production schedule; identifying batch specific requirements; weighing and measuring ingredients and adding to mixing equipment.
• Updates job knowledge by participating in training opportunities. Takes ownership for individual training plan.
• Responsible for reviewing all documentation including Batch records and Logbooks in “Real Time and Right First Time” and demonstrating error free documentations. Immediately reports any error or deviations noticed to management.
• Obtaining equipment and raw material for manufacturing and compounding.
• Follows all steps outlined in batch records, ability to actively perform all tasks being required by the batch record/ SOPs.
• Ability to perform a batch record review in real time.
• Operation of Autoclave.
• Obtaining PH
• Customer/Client Focus
• Ethical Conduct respect for others and solidarity
• Technical Capacity to operate and troubleshoot processing equipment.
• Conscientiousness for work and documentation

Qualifications & Requirements

• High School diploma with 2 years -Pharma/Biotech Manufacturing Support and 1 year- within Clean Room environments and some technical certification is desired in related field.
• Demonstrated ability to successfully gown into aseptic manufacturing areas.
• Excellent organization and time-management skills required. Must be able to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure.
• Must possess technical knowledge to operate and troubleshoot all operating equipment with minimal help.
• Environmental Monitoring, Water and product sampling.
• Fluent in English both written and spoken.
• Strong work ethic, Positive Attitude, Time Management, Problem Solving, Team Player, Self-Confidence & Ability to Accept & apply Lessons Learned as needed. Works with a sense of urgency, while engaging and listening to experts.
• Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills.
• Strong organizational skills with the proven ability to prioritize.
• Must be dependable and punctual.
• Proficient in the use of standard Microsoft Office software products, includingExcel, Outlook, Word
• Ability to handle sensitive information with a high degree of confidentiality.
• Must be flexible to work 1st or 2nd shift with holidays, weekends and overtime as per business needs. Work hours will be subject to change as required based on business demand and production workload.

Position Type

• On-Site

Travel

• None