Job Details
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:
Plans, organizes, and manages resources on projects to assure technical and regulatory quality, budget and schedule adherence
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 FDA and DEA regulations.
Assists with additional work duties or responsibilities as evident or required.
Primary Accountabilities:
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.
Participate in interactions with internal and external customers; lead meetings and/or record meeting minutes to support product development activities.
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 Teams, Smartsheet) in support of projects in order to facilitate statements of work and project plans.
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 Corporation's 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
Review and summarize process and batch data, conduct trend analysis, provide feedback and recommendation in assisting the timely resolution of technical and/or quality issues.
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.
Assists Analytical Services in administrative tasks such as maintaining training certifications or gathering supporting documentation. Supports dashboard maintenance, certification revision, Analyst and/or intern training schedule, intern.
Contribute to continuous improvements within the new product development process to improve communication and increase team productivity.
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 bachelors or master's degree in Chemistry, or Pharmaceutical-related science with a minimum of 3 years' experience in a cGMP related environment
Minimum 3 years' project management experience
Strong attention-to-detail, organization/multitasking, project management (planning, scheduling, documentation, project control), and teamwork skills with customer focus.
Strong interpersonal, verbal, and written communication skills.
Experience using analytical chemistry techniques such as HPLC, UPLC, GC, FT-IF, UV/Vis spectroscopy, wet chemistry, etc.
Computer experience (Microsoft Word, Excel, Power Point, 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 to meet shifting organizational and business demands.
The ability to effectively manage oneself, 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.