Description Corporate Statement: Nephron Pharmaceuticals 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, ophthalmic, 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. 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 some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust. Job Purpose: The CMC Product Development Project Manager plans, organizes, and coordinates with resources on assigned projects to assure technical and regulatory quality, budget and schedule adherence. The incumbent will assist in organizing and executing day-to-day operations of assigned product development and CMC regulatory-related projects in a high-growth, fast paced, dynamic work environment while ensuring compliance with regulations of applicable regulatory bodies such as FDA and DEA. The CMC Product Development Project Manager will also assist with additional work duties or responsibilities as evident or required. Essential Duties and Responsibilities: * Monitors schedule and progress for method development, method validation, and testing for formulation development and cGMP quality control activities as related to new products, manufacturing processes, and client-related projects. * Plans, organizes, and manages resources on regulatory projects to assure technical quality and schedule adherence * Ensures all development and technology transfer activities are aligned with Nephron Pharmaceuticals Corporations' project goals and timelines. * Supports activities related to drug product/process scale-up, technology transfer, validation, and manufacturing as CMO, including labeling and packaging. * Reviews product labeling * Use project management techniques to identify, develop, and maintain planning tools (e.g. spreadsheets, MS Project, MS Teams, Smartsheets) in support of product development projects * 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.) * Supports change control for research and development products and/or devices as well as established products * Participate in client and regulatory audits of facilities and quality system. * Works collaboratively with other departments such as Formulation, Engineering, Analytical Services, Quality and Regulatory to meet program goals. Coordinates seamlessly with colleagues who oversee formulation and analytical development activities. * Maintain all relevant project documentation, such as project plans, timelines, presentations, budget, status reports, etc. * Track formulation of new products, from development to commercialization, within defined company, industry, and regulatory parameters * Track development and implementation of analytical methodology associated with new products under development * Executes research and development projects for established products and new product development with respect to formulation, laboratory investigations, and early process development as needed * Participates in vendor evaluation and provides Analytical Services review of supplier documentation for compliance with regulatory requirements * Participates in development and review of analytical specifications and justification of specifications * Writes and/or reviews product development reports and CMC documentation to support IND, NDA, ANDA, and 510K submissions. * Develops solutions to complex technical and regulatory problems and investigation of unexpected results. * Communicates effectively and consistently in writing and verbally with all levels of staff and clients. Supplemental Functions: * Copying, filing, and scanning of documents. Performs other similar duties as required. Knowledge & Skills: * Capable of working in a GMP environment and responsible for generating GMP data. * Strong interpersonal, verbal, and written communication skills. Effective organization, multi-tasking, and problem-solving skills * Computer experience (Microsoft Word, Excel, Power Point, Smartsheets) * 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 Education/Experience: * Regionally accredited Master's degree in Chemistry or Pharmaceutical-related sciences and ability to work in a cGMP related-environment * A minimum of 2 years' experience in a cGMP related-environment * Skills and knowledge within research and/or product development gained through education and/or experience Working Conditions / Physical Requirements: * Position requires typing, climbing, lifting (up to 15lbs), reaching, vision (20/20), standing (10%), sitting (90%), walking, and hearing The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. Nephron Pharmaceuticals 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.