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:

• Provides support on R&D projects such as investigations, method validations, and aseptic process simulations.
• Participates on R&D Microbiology projects ensuring technical quality and schedule adherence.
• Performs other duties as assigned or apparent.
• Adhere to safety protocols, follow standard operating procedures (SOPs), and ensure compliance with relevant regulations, including OSHA and FDA guidelines.

Primary Accountabilities:

• Assists R&D Microbiology Analysts with protocols, summary reports, and studies. 
• Responsible for visual inspection and evaluation of media fill units.
  • Conducts media fill unit disposal following the appropriate procedures. 
• Performs activities in the Microbiology Laboratory such as: sample and waste destruction, sanitization of laminar flow hoods and biosafety cabinets, sample labeling and media growth promotion.
• Assists in the receipt, storage, organization, and disposal of media-filled units while ensuring proper documentation and compliance with FDA regulations. 
• Participates in the R&D media fill program by incubating media fill units, reviewing documentation, gathering attachments for reports and assisting on the production floor as needed. 
• Evaluates and documents media fill results. 
• Works in a cGMP environment and responsible for generating cGMP data. 
• Maintains equipment records and daily work logs related to R&D Microbiology activities. 
• Supports the R&D Project Coordinator and Manager on tracking projects and deadlines.
• Assists the R&D Microbiology Analysts with investigations by gathering attachments and ensuring documentations is accurate. 
• Communicates Microbiology-related observations, issues, problems, discrepancies, and any violation of company policies or procedures to R&D Microbiology Manager, 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.

Knowledge, Skills & Abilities:

· High School Diploma; Regionally accredited Bachelor’s science degree, preferred.

· Experience with the pharmaceutical industry, cGMP, and aseptic techniques preferred. 

· Must be open to receive training in other areas and accept changes in order to achieve department demands. 

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

· Must have strong communication, documentation and time management skills; and must maintain a strong attention to detail.

· The ability to meet deadlines and adapt to department needs.

· Flexible and open to receive training in multiple areas. 

· The ability to effectively work independently, demonstrate integrity, and perform under pressure.

· The ability to spend at least 6 hours a shift performing visual inspection of media fill units.

· Specific expertise, skills and knowledge within research, product development, gained through education and/or experience.

· 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.

· Possesses the initiative and follow through to implement, track and achieve on-time completion of projects, as assigned by management. 

· Position requires typing, climbing, lifting (up to 15lbs), reaching, vision (20/20), standing (10%), sitting (90%), 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.