Research and Development Special Projects Coordinator

Corporate Statement

Nephron Pharmaceuticals Corporation is a privately-owned global leader in manufacturing 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. This niche technology 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 various 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 covering 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:

· To initiate, oversee, evaluate, and support incoming/out-going results from Analytical Services to NPC internal customers (R&D Formulation, R&D Engineering, Stability, and Validation) and external customers for various projects, which may or may not include New Drug Products (NPC or NOF), Early Phase Drug Product Evaluations, Product Development Protocols, ANDA/ NDA submissions, and Extractables/Leachables program.

· To assist in the notification of testing needs to AS management for NPC internal customers.

· To manage the release of results associated with NPC internal customers and communicate any delays or progress to NPC internal customers and AS management.

Primary Accountabilities:

• Capable of working in a GMP environment and responsible for generating GMP data.
• Capable of evaluating and reporting results of different analytical techniques, including but not limited to HPLC, UPLC, GC, Automatic Titrator, IR, DSC, ICP, and Mass Spectrometry.
• Capable of supporting protocol and summary report drafts related to CMC submissions and other Regulatory activities required for submissions.
• Responsible for supporting laboratory notebook reviews for the release of results to NPC internal customers.
• Responsible for communicating with NPC internal customers regarding completion of the testing analysis, ongoing investigations, or questions regarding sample submissions or reporting.
• Responsible for communication with AS management regarding testing deadlines or requirements from internal customers.
• Capable of evaluating results for NPC internal customers for release and discuss any Out of Specification or Out of Trend Results with AS management.
• Assists in maintaining and release, where necessary, results to NPC internal customers (LIMS / 1253 Forms) and ensures results are released to the appropriate specifications and limits.
• Capable of supporting the training of various tasks or testing, as deemed necessary.
• Responsible for Research and Development projects for established products and new product development concerning results associated with formulation, laboratory investigations, and early process development.
• Responsible for evaluating new raw materials and components for quality and safety before implementation into exhibit batches and GMP production.
• Responsible for developing and validating analytical methods for pharmaceutical ingredients and dosage forms, including the establishment of specifications.
• Oversee and ensure reports, submission documentation, and Development summaries documenting the product development process are available for clients, partners, and health authorities (i.e., FDA)

NOTE: The primary accountabilities above and the knowledge, skills, and abilities listed below are intended to describe this position's general content and requirements 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:

· Regionally accredited Bachelor's Degree in Chemistry and a minimum of 5 years of previous experience in a cGMP related environment or Master's Degree in Chemistry and a minimum of 5 years of prior experience in cGMP related environment

· Highly skilled in conducting analysis or evaluating analysis by HPLC, UPLC, GC, FT-IR, UV/Vis spectroscopy, and wet chemistry techniques, needing little or no guidance.

· Strong interpersonal, verbal, and written communication skills. Effective organization, multi-tasking, and problem-solving skills

· Computer experience (Microsoft Word, Excel, PowerPoint, Project)

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

· The ability and willingness to change direction and focus on meeting shifting organizational and business demands

· The ability to effectively manage one's 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.

· Must strive for continuous improvement in all work activities.

· The ability to take strategic objectives and accept accountability, motivate and influence others thinks globally, and leverages diversity

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

· Additional Requirements: As needed

. Salary range: Based on experience

EEOStatement:

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.