R&D Microbiology Manager

Description:

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. 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:

· Responsible for management and oversight of the R&D Microbiology program.

· Oversees and executes research and development (R&D) projects for both established and new products including, but not limited to, protocol preparation/approval, microbiological test method validations, drafting test methods, conducting and reviewing investigations, media fill management, and other general projects or initiatives.

· Manages priorities and ensures associated projects meet specified timelines related to product release and/or product development.

· Other duties as assigned or necessary.

Primary Accountabilities:

· Manages R&D activities and staff within the Microbiology Department.

· Attends meetings as an R&D representative and communicates with other departments to organize projects, review procedure deviations, and conduct re-trainings.

· Manages assignment and review of Method Validation documents, excursions, and media fill protocols and summary reports.

· Reviews and/or writes Microbiology procedures, R&D and Quality Control protocols, test method validations, and various summary reports.

· Coordinates assignments of excursion reports related to environmental monitoring (EM) and laboratory testing and provides coaching and support for all investigators.

· Manages the development of media fill protocols and coordinates with production to ensure proper execution and completion of the protocols, as needed.

· Provides insight to other departments to determine Microbiological impact to product, machines, cleanrooms, and any other areas of the facility requiring assessment, as necessary.

· Provides input to Environmental Monitoring and Quality Control divisions of Microbiology, as needed or necessary based on tasks or assignments.

· Conducts performance evaluations of Microbiology R&D staff and assists R&D Microbiology Supervisor in personnel disciplinary actions.

· Assists Microbiology management with development of solutions to any chronic problems, should issues arise.

· Communicates Microbiology-related observations, issues, challenges, discrepancies, and any violations of company policies or procedures to the Assistant Director of Microbiology, Director of Microbiology, or designee.

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

Requirements:

Knowledge, Skills & Abilities:

· Regionally accredited Master’s Degree in Microbiology with 2-4 years experience, and/or a Bachelor’s Degree in Biological Sciences / Microbiology, with minimum of 5 years of laboratory experience in cGMP related environment preferred.

· Prior pharmaceutical industry supervisory experience necessary.

· Extensive knowledge of cGMP, USP guidelines, aseptic processing, aseptic environmental monitoring techniques and laboratory method performance.

· Highly skilled in conducting and understanding microbiological analysis such as identification, morphological analysis, endotoxin testing, sterility, etc.

· The ability to identify work elements in detail, and develop work standards and work method improvements; develop procedures and forms to promote method improvement and simplification.

· Specific expertise, skills, and knowledge within microbiology gained through education and experience.

· Ability and willingness to change direction and focus to meet shifting organizational and business demands.

· Proficient in programs used by the Microbiology Lab such as LIMS and MODA.

· Computer experience (Microsoft Word, Excel, Power Point, Microsoft Project, etc.)

· Flexibility in meeting shifting organizational and business demands.

· Maintains a broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.

· Self-directed, demonstrates integrity, productive under pressure, and achieves development goals.

· Strive for continuous improvement in all work activities.

· The ability to effectively allocate resources, and to be accurate and current with data and information.

· Position requires typing, climbing, lifting (up to 15 lbs), reaching, vision (20/20), standing (20%), sitting (80%), walking, and hearing.

· Salary range: Based on 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, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.