QC Microbiology & Stability Scientist
Harrow, Inc.Ledgewood, New Jersey, United States · Posted 1 month agoDescription
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
This position is responsible for performing microbiological testing, data review, and managing stability program activities in support of product quality, regulatory compliance, and GMP manufacturing. Assist with the QC samples, including raw materials, stability, and finished drug products. This role supports environmental monitoring, microbial testing, stability studies, and data review while ensuring adherence to regulatory requirements and internal quality standards.
Core Responsibilities
- Ensure compliance with GMP, FDA, and ICH guidelines.
- Prepare and maintain laboratory documentation, including SOPs, protocols, and reports.
- Participate in internal audits, regulatory inspections, and quality improvement initiatives.
- Support deviation investigations, CAPAs, and change control activities.
- Handles all QC samples, including raw materials, finished drug products, and stability samples, for submission to appropriate analytical testing laboratories, including making out submission paperwork or entry forms and shipping the samples to outside laboratories
- Follows up with laboratories on past due test results
- Other duties will be assigned as required to support QC and Quality
QC Microbiology
- Perform routine and non-routine microbiological testing, including:
- Environmental monitoring (air, surface, personnel)
- Bioburden testing
- Microbial limits testing
- Endotoxin testing
- Sterility testing (as applicable)
- Conduct microbial identification using approved methods.
- Perform media preparation, growth promotion testing, and equipment qualification.
- Review microbiological data and ensure accuracy, completeness, and compliance with GMP requirements.
- Investigate out-of-specification (OOS), out-of-trend (OOT), and environmental monitoring excursions.
- Support method validation, method transfers, and laboratory investigations.
Stability Program Management
- Coordinate and manage stability studies in accordance with ICH and regulatory guidelines.
- Prepare and maintain stability protocols, schedules, and reports.
- Manage stability sample inventory, storage, and testing timelines.
- Track stability time points and ensure timely testing and documentation.
- Review and analyze stability data to support product shelf-life and regulatory submissions.
- Maintain stability chambers and monitor environmental conditions.
- Enters all stability sample information and data into the stability management software
- Provides stability data and analysis for Annual Product Quality Review (APQR) reports.
Qualifications & Requirements
- Bachelor’s Degree in scientific discipline.
- 5 years of pharmaceutical laboratory environment experience; or equivalent combination of education and experience.
- Must be detail oriented
- Must be well organized
- Must have the ability to work on multiple different tasks within a workday
- Must have a positive teamwork attitude
- Excellent interpersonal, oral, and written communication skills
- Maintains confidentiality of sensitive information
- Ability to meet attendance standards. All full-time employees are required to work a minimum of 40 hours in a week. Sometimes it may be necessary to work additional hours to accomplish the required tasks to meet deadlines
Position Type
- On-Site
Travel
- None
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