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Description
Job Title:
CMC Product Development Senior Manager
Reports To
Vice President of CMC Product Development
FLSA Status
Exempt
Company: Nephron SC, LLC
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 Senior Manager oversees all aspects of Product Development and CMC Regulatory Affairs and will plan, organize, and manage resources on projects to assure technical and regulatory quality, budget and schedule adherence. The incumbent will assist in coordinating and overseeing the day-to-day operations of assigned-product 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 Senior Manager will also assist with additional work duties or responsibilities as evident or required.
Essential Duties And Responsibilities
- Support project management administration to assigned products/contract manufacturing projects such as resource planning, meeting notes, developing timelines and overall project communication and follow-up.
- Support the Product Development Team to develop strategic product development and CMC regulatory plans for new products, manufacturing scale up and contract manufacturing services.
- Lead and/or facilitate client discussions to create alignment on critical deliverables
- 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
- Maintain all relevant project documentation, such as project plans, timelines, presentations, budget, status reports, etc.
- Coordinates activities of project personnel to ensure project progresses on schedule and within prescribed budget.
- Communicates effectively and consistently in writing and verbally with all levels of staff and clients
- Monitors schedule and progress for method development, method validation, and testing for formulation development and cGMP quality control activities as related to new products and client-related projects.
- Ensures all development and technology transfer activities are aligned with Nephron Pharmaceuticals’ project goals and timelines.
- Develop and/or review documentation related to new product development such as protocols, SOPs, and specifications
- Supports activities related to drug product/process scale-up, technology transfer, validation, and manufacturing as CMO, including labeling and packaging.
- Participate in client and regulatory audits of facilities and quality system as assigned
- 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.
- Prepare proposals for new product development for both new business and existing projects.
- Support new product Business Development ensuring full customer support for contract manufacturing planning and project execution.
- Participates in the development, review, and implementation of Equipment/Process/Material changes and associated programs (e.g. cleaning validation, process validation, GMP compliance, equipment validation, maintenance and use, etc.)
- Responsible for communicating status updates of research and development projects for established products and new product development with respect to manufacturing process development.
- Ensure reports, submission documentation, and development summaries documenting the product development process are available for clients, partners, and health authorities (i.e. FDA).
- Oversee the preparation of CMC documents required for various regulatory submissions
- Review CMC regulatory submission documents and CMC-related technical documentation
- Participates in vendor evaluation and oversees review of supplier documentation for compliance with regulatory requirements
- Assists staff in developing solutions to complex technical and regulatory problems.
- Contribute to continuous improvements within the new product development process to improve communication and increase team productivity.
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, 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 upper 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 Bachelor’s degree in Chemistry or Pharmaceutical Sciences and
- A minimum of 4 years’ experience in a cGMP related-environment
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.
