Vice President Of Microbiology

Corporate Statement

Nephron Pharmaceuticals Corporation is a privately owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron’s products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina, with additional distribution centers in Kentucky and Arizona. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmics, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention.

As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. Nephron is currently working on research and development projects that include over 50 new products. The company’s longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long term care facilities. Nephron has a sales force that covers all fifty states and Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe. Nephron exists to provide top-quality, affordable medications to everyone.

Position Summary:

• Oversees daily performance of assigned duties for the Microbiology Department, providing support to Production, R&D Engineering, Product Development, and other departments, as well as executive management.
• Assists with additional work duties or responsibilities as evident or required.

Primary Accountabilities:

• Establish functional and performance metrics for sterility testing and environmental monitoring.
• Reports directly to executive leadership regarding all microbiological concerns and accomplishments.
• Manages Microbiology operation areas and personnel for adherence to all cGMP, SOP, and safety regulations, and ensures the department is compliant with all regulatory requirements.
• Oversees operation of the Microbiology Department including Quality Control/Release testing, R&D Microbiology, and Environmental Monitoring Program.
• Ensures the Microbiology lab orders all required testing materials, equipment, and services.
• Participates in and provides any documentation needed for internal and external audits.
• Ensures all excursions, investigations, and quality events are complete by assigned deadlines.
• Performs TrackWise responsibilities and ensures all Microbiology PR’s are completed by assigned due dates.
• Ensures the completion and final review of summary reports, trending reports, and other work generated from testing.
• Manages initiatives, campaigns, and special projects, as needed.
• Ensures professionalism and productivity of all Microbiology staff.
• Reviews, writes, and approves procedures and method validation protocols/summary reports.
• Report to executive leadership team any microbiological concerns and accomplishments
• Responsible for completion of management review presentation monthly, and presenting on behalf of the department.
• Ensure site contamination control strategy is current and that an annual review is completed.

NOTE: The primary accountabilities above are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

Knowledge, Skills & Abilities

• 5-10 years+ of experience with MS Word, Excel, and PowerPoint, preferred.
• Regionally accredited Biology, Microbiology, or Life Science Degree, Master’s or PhD preferred.
• Salary range: Based on experience
• Additional Requirements:
• The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• Experience in Root Cause Analysis of Microbiological excursions, media fill design/execution and drug product sterility investigations.
• The ability to work independently, demonstrates integrity, be productive under pressure, and achieve development goals.
• 10 years+ of management and coordination experience.
• The ability to manage a multitude of resources and to be accurate and current with data and information.
• Position requires bending, typing, climbing, lifting, reaching, standing, sitting, walking, and hearing.
• USP guidelines, CGMP, Aseptic Processing, Aseptic Environmental Monitoring techniques and methods, Microbiological quality control testing.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• 10 years+ prior Pharmaceutical Industry/Management experience preferred.
• Specific expertise, skills, and knowledge within Microbiology gained through education and experience.

EEO Statement:

Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.