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Form of workJob 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:
• Support quality control testing and research and development activities as needed.
• Assists with additional work duties or responsibilities as evident or required.
• Performs other duties as assigned or apparent.
• Relies on experience and judgment to plan and accomplish goals.
• Perform a variety of tasks and works under general supervision.
Primary Accountabilities:
NOTE: The Primary Accountabilities below 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.
Specific tasks or responsibilities will be documented in the incumbents' performance objectives as outlined by the incumbents' immediate supervisor or manager
• Conduct routine laboratory testing for raw materials, in-process materials, finished product and stability samples in accordance with approved analytical methods.
• To conduct laboratory work using best-practice analytical techniques, and to consistently follow laboratory GDP and cGMP requirements.
• Perform calibration and routine maintenance of lab equipment as necessary and participate in troubleshooting and minor repair of instrumentation.
• Execute and report the results of R&D protocols such as methods validations and vendor evaluations to ensure smooth transfer of validated methods from R&D to QC.
• To verify notebooks, raw data, and COA’s and, on occasion with management authorization, to provide final QC approval for release. • To provide training for chemists as needed and directed by management.
Requirements:Knowledge, Skills & Abilities:
• BS or MS in Chemistry, Biochemistry or a related field required with 2-5 years of pharmaceutical experience preferred. Experience outside of pharmaceuticals in chemistry quality control or R&D will be considered for the highly qualified candidate.
• Highly skilled in conducting analysis by HPLC, GC, FT-IR, UV/Vis spectroscopy as well as wet chemistry techniques, needing little or no guidance.
• Must possess excellent analytical skills and problem solving ability, strong attention to detail, sound understanding of cGMP regulations pertaining to laboratory controls and a thorough knowledge of USP and compendia standards.
• Ability to design, write, review and update standards operating procedures forms and specifications and design new procedures independently, subject to management review.
• Ability to perform testing and lead root cause analysis for laboratory investigations for OOS and atypical QC test results, subject to management review.
• Ability to assist R&D in the development and execution of method development and method validation protocol and reports.
• Ability to effectively communicate with laboratory staff and management as well as other departments and external customers as directed by management.
• Possess the initiative and follow through to implement, track and achieve on-time completion of projects, as assigned by management.
• 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 vision (20/20), standing (40%), sitting (25%), talking, hearing, typing and walking (35%).
• Position encounters the following environmental factors: hazardous materials including HPLC solvents, chemical reagents, acids and other non-specified hazardous materials that are project specific.
• Position requires safety glasses, respiratory and other non-specified protective equipment to be worn 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, 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.
