Microbiologist

Harrow (Nasdaq: HROW) is a leading U.S. ophthalmic-focused pharmaceutical company. The Company was founded and continues operating based on the highest corporate values. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to and affordability of our 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. At Harrow, we foster our individual and collective entrepreneurial and creative spirits. We focus on pursuing opportunities for drug candidates in underserved markets. We are data-driven and use our access to real-world clinical experience to lower the investment risks of our work. We concentrate on the commercial appeal of high-value assets, and our objective is to seek to make paradigm-shifting medicines available to patients as soon as possible. Our approach to finding high-value opportunities and balancing risk with real-world experience can deliver exceptional value for all our stakeholders. Harrow’s ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including: IHEEZO: A broad Dry Eye Disease product line, led by VEVYE® and bolstered by well-known adjacent ocular surface disease products such as FLAREX® and TOBRADEX® ST; TRIESENCE®: A Specialty Anterior Segment product line, which includes various high-need and utility products such as ILEVRO®, NEVANAC®, and VERKAZIA®; ImprimisRx is the nation’s leading ophthalmology-focused compound pharmacy, including an FDA-registered and FDA-inspected 503B outsourcing facility and a 50-state mail-order pharmacy. The Harrow division serves as an innovation hub and plays a vital role in Harrow’s mission to help patients maintain their gift of sight. Job Summary Under the leadership of the Quality Control Manager, the Microbiologist is responsible for performing in-process and finished product release testing. The position requires attention to detail, strong organizational skills, computer proficiency, and a basic understanding of microbiology and laboratory instrumentation. In addition, practical communication skills and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success. Ensures test methods are qualified/validated and performed under cGMP requirements. Performs various duties related to the efficient and effective functioning of a Quality Control lab. Assists in reviewing and modifying SOPs and other lab documents as necessary. Position Responsibilities Perform Microbiological testing and method validations related to USP 71 Sterility Kinetic/chromogenic Endotoxin assay This position will also be a backup for viable and non-viable environmental monitoring and membrane filtration-based bioburden testing. Perform microbiological testing following laboratory methodologies, such as Testing Standards, General Method, Specific Method, Pharmacopeia Compendia, and SOPs. Report any non-conformances. Initiate and lead resolution efforts and laboratory investigations. Maintain a clean and safe working environment; adhere to existing safety protocols and participate in department safety programs. Report results accurately and maintain good recordkeeping. Responsible for routine laboratory upkeep and organization. Maintain the QC laboratory's laboratory supplies, media, and reagents inventory. The ideal candidate is self-driven, task-oriented, and can work independently but must meet deadlines. Comply with all applicable company and site policies and procedures and all regulatory and FDA guidelines. Assist in reviewing and modifying SOPs and other lab documents as necessary. Manages preventative maintenance and calibration activities on QC instrumentation. Requirements and Qualifications BS or BA degree in Microbiology or Biology 5-7 years of relevant microbiology lab experience in a cGMP/FDA-regulated industry. Strong interpersonal skills, including communicating in oral and written forms effectively and efficiently at any level within the organization and interacting effectively with customers and external business professionals. Ability to work independently or as a team member. Demonstrated hands-on knowledge in Microbiology and USP 71 sterility testing required. Ability to problem-solve and troubleshoot as necessary. Ability to identify and implement process improvements and creative or novel solutions under minimal supervision. Commitment and drive to improve manufacturing operations. Work Environment/Physical Demands The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand, walk, use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, and crouch. The employee must occasionally lift and/or move up to 25 pounds. A cleanroom environment requires wearing gowning in hospital scrubs, bunny suits, gloves, and steel-toe boots. Also, no makeup or jewelry can be worn when working in a clean room environment. Specific vision abilities in this job include close vision, depth perception, and the ability to adjust focus. #J-18808-Ljbffr