Research and Development CMC Regulatory Scientist

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:

· Responsible for writing and reviewing technical documentation for regulatory submissions pertaining but not limited to Product Development reports and any chemistry, manufacturing and controls (CMC) sections.

· Work with cross-functional teams to support regulatory CMC activities for drug product and medical device submissions.

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

Primary Accountabilities:

· Capable of working in a GMP environment and responsible for generating GMP data. 

· Use project management techniques to identify, develop, and maintain planning tools (e.g. spreadsheets, MS Project, MS Teams, Smartsheets) in support of CMC regulatory/ product development projects 

· Supports regulatory projects to assure technical quality and schedule adherence

· Responsible for executing research and development projects for established products and new product development with respect to formulation, laboratory investigations, and early process development as needed

· Supports change control for research and development products and/or devices as well as established products 

· Writes product development reports and CMC documentation to support IND, NDA, ANDA, and 510K submissions.

· Participates in the development and implementation of Equipment/Process/Material changes and associated programs (e.g. cleaning validation, process validation, GMP compliance, equipment validation, maintenance and use, etc.)

· Ensures reports, submission documentation, and development summaries documenting the product development process are available for clients, partners, and health authorities (i.e. FDA)

· Develops solutions to complex technical and regulatory problems and investigation of unexpected results.   

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:

· Regionally accredited Bachelor’s degree in Chemistry or Pharmaceutical Sciences and a minimum of 2 years’ experience in a cGMP related-environment

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

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

· 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. 

· 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

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.