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:

• Conduct extractions and unknown analysis on container closure systems using Mass Spectroscopy methodologies (organic and inorganic).

• Elucidate organic compound structural features using sound scientific rationale and experimental methodologies.

• Conduct method validations for mass spectroscopy-based methodologies including LCMS, LC-MS/MS, GCMS DI, GCMS HS, and ICP-MS.

• Perform Product Matrix Evaluations for drug products as it relates to Leachable screening methodologies.

• Provide guidance and support to Leachable testing of Stability Samples.

• Perform other duties as deemed necessary.

NOTE: The Primary Accountabilities and Knowledge, Skills and Abilities 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.

Primary Accountabilities:

• Extractables and Leachables testing to evaluate container closure systems and product specific safety thresholds.

• Detail-oriented evaluation of spectral data to elucidate unknown compound structures.

• Utilize Extractable databases for Leachable screening.

• Method validation activities according to USP and ICH guidelines as it pertains to Mass Spectroscopy-based methodologies.

• Support Leachable testing of Stability samples for ANDA submission purposes.

• Leadership by example and Mentoring activities for development of the MSC team.

• Drafting Protocols and Summary Reports and Reviewing the work of Peers.

Knowledge, Skills & Abilities:

• BS in Chemistry, Biochemistry or a related field required with 1-2 years of pharmaceutical experience preferred; or MS in Chemistry, Biochemistry or a related field required with 0-2 years of pharmaceutical experience preferred. Experience outside of pharmaceuticals in chemistry quality control or R&D will be considered for the highly qualified candidate.

• Experience with conducting analysis by Liquid Chromatography, Gas Chromatography, and Mass Spectroscopy methodologies.

• Experience with elucidation of unknown compounds using Tandem Mass Spectroscopy methodologies.

• Must possess strong analytical skills and problem-solving ability, and show attention to detail, understanding of cGMP regulations pertaining to laboratory controls and knowledge of USP and compendia standards.

• Ability to review and update standard operating procedures, forms, and specifications.

• Ability to design new procedures as necessary under management guidance.

• Ability to effectively communicate within chemistry laboratory staff and management.

• Ability to effectively articulate scientific rationale to a general audience and write thorough summary reports for summarizing experimental findings.

• Must strive for continuous improvement in all work activities and be able to nurture the educational growth of peers in open discussions and training seminars.

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

• Position requires, 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.

• 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, marital status, genetic information, pregnancy, 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.