Senior Microbiologist

About Harrow

Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an entrepreneurial company where every team member is empowered to be the CEO of their role. Our values attract high-performing professionals across disciplines, and our team takes pride in:

• Innovation
• Patient access to affordable medicines
• A track record of supporting ophthalmologists in mission work worldwide by providing free medicines to those in need

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

• An expanding Retina Portfolio: IHEEZO®, TRIESENCE®, BYOOVIZ™, and OPUVIZ™
• A broad Dry Eye Disease product line, led by VEVYE® and supported by FLAREX® and FRESHKOTE®
• A peri-operative Surgical product line, led by TRIESENCE® and BYQLOVI™
• A Rare and Specialty product line, including ILEVRO®, NATACYN®, and VERKAZIA®
• A robust internal development pipeline with late-stage candidates such as MELT-300, MELT-210, H-N08, and CR-01

Responsibilities

• Perform and oversee microbiological testing including:
  • USP <71> 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, customer audits, and regulatory inspections by preparing documentation and presenting microbiological data.
• Manage laboratory equipment qualification, calibration, maintenance, and lifecycle activities.
• Ensure laboratory supplies, media, standards, and reagents are properly maintained and available.
• Mentor and train microbiology personnel on laboratory techniques, procedures, data integrity, and compliance requirements.
• Drive continuous improvement initiatives to enhance laboratory efficiency, compliance, and operational excellence.
• Maintain a clean, safe, and inspection-ready laboratory environment.
• Comply with all company policies, site procedures, FDA regulations, USP requirements, and applicable cGMP standards.

Requirements

Education

• Bachelor's degree in Microbiology, Biology, Molecular Biology, or related Life Sciences field required.
• Master's degree preferred.

Experience

• Minimum 7–10 years of progressive microbiology experience within a cGMP/FDA-regulated pharmaceutical, biotechnology, medical device, or compounding environment.
• Minimum 3 years of direct experience performing USP <71> sterility, USP <85> Endotoxin, Bioburden testing, and microbiological method validation activities.
• Experience leading microbiological investigations and contamination control initiatives.
• Experience supporting regulatory audits and inspections preferred.

Technical Knowledge

• Advanced knowledge of:
  • USP <71> Sterility Testing
  • USP <85> Bacterial Endotoxin Testing
  • USP <61>/<62> Microbial Enumeration and Specified Organisms
  • Environmental Monitoring Programs
  • Cleanroom microbiology
  • Aseptic processing principles
  • Laboratory investigations
  • Data trending and statistical analysis
• Strong understanding of FDA regulations, USP requirements, cGMP standards, and data integrity principles.
• Proficiency with laboratory instrumentation, LIMS, electronic quality systems, and Microsoft Office applications.

Competencies

• Strong leadership and mentoring capabilities.
• Exceptional written and verbal communication skills.
• Demonstrated ability to manage multiple priorities and projects independently.
• Strong analytical, troubleshooting, and root cause investigation skills.
• Ability to identify process improvements and implement effective solutions.
• Results-oriented with a commitment to quality, compliance, and continuous improvement.

Schedule

This is an on-site position with up to 5% travel required.