Lead R&D Microbiologist

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:

· Design, development, and validation of new products, including, but not limited to, microbiology test method validation/transfer/verification, procedures, investigations, manufacturing process, media fills, and other non-specified projects or initiatives.

· Assists with additional work duties or responsibilities as evident or required.

· Performs other duties as assigned or apparent.

Primary Accountabilities:

· Defines strategic objectives for the Microbiology R&D team, as well as generating and implementing initiatives that improve departmental efficiency and quality of results.

· Leads a technical team from the beginning through the end of different R&D projects: project triage, scheduling, workload, timeframe, inventory, testing, management and external communications, documents, project closing, etc.

· Designs, writes, and conducts new test method development with respect to new products.

· Works effectively with different analytical techniques, including all Microbiology Quality Control methods.

· Conducts the development and validation of special projects as related to Microbiology.

· Drafts SOPs related to R&D functions, equipment, documentation, and processes, including protocols and summary reports.

· Drafts, reviews and approves protocols, summary reports, lab reports, investigations, media fill protocols and summary reports, method validations, and/or laboratory notebooks.

· Contributes to other non-specified projects and initiatives of the R&D division, as needed.

· Participates in reading and documenting media fill results.

· Capable of working in a cGMP environment; generates cGMP data and understands the guidance and regulations which dictate data integrity.

· Communicates Microbiology-related observations, issues, problems, discrepancies, and any violation of company policies or procedures to R&D Microbiology Supervisor, R&D Microbiology Manager, Assistant Director of Microbiology, Director of Microbiology, and/or designee.

· Participates in the development and implementation of associated programs (e.g. cleaning, validation, process validation, cGMP compliance, equipment validation, maintenance and use, etc.).

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 Bachelor Degree in Microbiology required, Master’s degree or above preferred.

o At least 4 years of experience with analytical method development, validation, and product development projects.

o 4-6 years of experience working directly with microbiology QC methods including bioburden, sterility, endotoxin testing. 2-4 years of experience writing and performing method validations.

· Skills to lead technical teams throughout different R&D projects as needed: method development and validation, product development, complex investigations, process development, etc.

· Expert in the theory of and in conducting analysis in microbiology methods specific to QC and method validation.

· Must possess excellent analytical skills, problem solving ability, attention to detail, and have an expert understanding of cGMP regulations pertaining to laboratory controls and USP and compendial standards.

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

· The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.

· The ability to create new products and processes that add value to the Business, by generating new ideas and applying creative and analytical approaches.

· Ability to effectively communicate with laboratory staff and management as well as other departments and external customers under general management supervision.

· Possesses the initiative and follow through to design, implement, track and achieve on-time completion of projects independently.

· Must strive for continuous improvement in all work activities.

· The ability to effectively use a multitude of resources and to be accurate and current with data and information.

· Position requires bending, typing, climbing, lifting, reaching, vision (20/20), standing (SO%),

o sitting (30%), walking (20%), gripping and hearing.

· Position encounters the following environmental factors: hazardous materials including flammables and other non-specified hazardous materials that are project specific.

· Incumbents are required to wear safety glasses, laboratory coat and other non-specified protective equipment as necessary.

· Additional Requirements:

· 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, 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.