Senior Microbiologist

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.

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

Under the leadership of the Director of Quality, the Senior Microbiologist is responsible for leading and performing microbiological testing, method qualification and validation activities, environmental monitoring oversight, and microbiological investigations in support of sterile pharmaceutical manufacturing operations. This position serves as a subject matter expert (SME) for microbiology-related processes and provides technical guidance to Quality Control personnel.

The Senior Microbiologist ensures all testing activities comply with current Good Manufacturing Practices (cGMP), USP requirements, FDA regulations, and company procedures. The role requires advanced technical expertise, strong analytical and problem-solving skills, and the ability to independently manage complex projects and investigations while supporting continuous improvement initiatives within the Quality Control Laboratory.

• Perform and oversee microbiological testing including:
  • USP Sterility Testing
  • Bacterial Endotoxin Testing (BET) using kinetic and chromogenic methods
  • Bioburden testing
  • Microbial identification
  • Growth promotion testing
  • Water system monitoring and testing, as applicable.
• Serve as the microbiology subject matter expert for laboratory operations, product release testing, investigations, and regulatory inspections.
• Lead method qualification, validation, transfer, verification, and lifecycle management activities for microbiological test methods.
• Review and approve laboratory data, test results, protocols, reports, and associated documentation.
• Lead laboratory investigations related to out-of-specification (OOS), out-of-trend (OOT), environmental monitoring excursions, contamination events, deviations, and non-conformances.
• Conduct root cause analyses and develop effective corrective and preventive actions (CAPA).
• Provide technical support for aseptic processing operations, contamination control strategies, and cleanroom environmental monitoring programs.
• Serve as a backup and technical lead for viable and non-viable environmental monitoring activities.
• Evaluate and trend microbiological data to identify adverse trends and recommend improvements.
• Author, review, and revise SOPs, protocols, validation documents, risk assessments, technical reports, and laboratory procedures.
• Support internal audits,…