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:

• Creates and executes Microbiology project work plans as it pertains to product development initiatives, and revises, as appropriate, to meet changing needs and requirements of the department.
• Plans, organizes, and manages microbiology resources on projects to assure technical and regulatory quality and schedule adherence. 
• Assists 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. 
• Reports to upper management on project status. 

Primary Accountabilities:

· Supports project management administration regarding assigned products/contract manufacturing projects; ensures all Microbiology requirements for product development resource planning, timelines, and overall project communication are complete and effective. 

· Bridges the gap between Microbiology and other departments in regards to product development timelines and expectations. 

· Communicates effectively and consistently in writing and verbally with all levels of staff. 

· Monitors schedule and progress for method development, method validation, and testing for development and cGMP quality control activities as related to new products.

o Utilizes project management techniques to identify, develop, and maintain planning tools in support of project plans and timelines (e.g. spreadsheets, Smartsheets, etc.).

· Provides Microbiology SME approval on all development documentation; reviews and summarizes process and batch data, provides feedback and recommendations to assist the timely resolution of technical and/or quality issues. 

· Develops and/or reviews Microbiology documentation related to new product development such as protocols, SOPs, and specifications.

· Establishes a timeline for each phase of projects, as well as a completion date for the entire project.

· Ensures project documents are complete and current, and all documentation is performed as necessary.

· Ensures all documentation is completed prior to the closure of projects.

· Responsible for Standard Operating Procedure (SOP) review, revision, and creation.

· Identifies operational and training improvements and follows them through to completion.

· Reviews documents for authorization and approval of required or needed changes and ensures correctness and completeness. 

· Contributes to continuous improvement initiatives within Microbiology to improve the product development support process.

· Works with other Microbiology Project Manager(s) to ensure coordinated initiatives are assigned and communicated between all microbiology personnel.

· Communicates Microbiology-related observations, issues, problems, discrepancies, and any violation of company policies or procedures to R&D Microbiology Manager, Assistant Director of Microbiology, Director of Microbiology, or designee. 

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 or master’s degree in Microbiology, Chemistry, or pharmaceutical-related science with a preferred minimum of 3 years’ experience in a cGMP related environment. 
• Strong attention to detail, organizational and multitasking ability, and project management experience. 

· 1-3 years of experience with MS Word, Excel, PowerPoint, and project management software (MS Project, Smartsheets, or other related programs).

· 1-2 years project management and coordination experience.

· Ability to organize and coordinate projects effectively.

· Must possess excellent written and oral communication skills.

· The ability to manage a multitude of resources and maintain accurate and current data and information.

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

· The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.

· The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business.

· 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.

· The ability to create new products and processes that add value to the Business, by generating new ideas and applying creative and analytical approaches.

· Specific expertise, skills and knowledge within training and special projects gained through education and experience.

· A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities.

· The ability to take strategic objectives and accept accountability to drive results through effective actions.

· Salary range: Based on experience

· Hours of work: Monday thru Friday on an 8 hour shift, or as needed based on company demand.

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.