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Manager of Chemistry Analytical Services

Department: Chemistry
Location: West Columbia, SC

SC Manager of Chemistry Analytical Service

Corporate Statement

Nephron Pharmaceuticals Corporation is a privately owned global leader in the manufacturing of generic respiratory medications. We are headquartered in West Columbia, SC. All Nephronís products are proudly made in the USA! Our new SC 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 will utilize completely automated manufacturing, packaging, and distribution systems, in addition to, high volume and redundant utility systems that will ensure production system availability. Nephron specializes in blow-fill-seal (BFS) manufacturing, a technology that allows a vial of medication to be formed, filled and sealed in a continuous process without human intervention, and in a sterile, enclosed area.

As an industry leader in product safety and quality, Nephron continuously pursues product enhancements, such as easy to identify vial shapes, embossed lettering and color-coded packaging. In 2001, prior to FDAís 2004 mandate, Nephron led the market in the development and release of individually wrapped and bar-coded medication. Individually wrapped and bar-coded vials are a major patient safety feature and are now standard treatments in the bedside safety practices of US hospitals.

  

Nephron has longstanding relationships with major drug wholesalers to distribute its products among retail pharmacies, mail order pharmacies, hospitals, home care companies, and long term care facilities. Nephron has a dedicated sales force that covers all fifty states and Puerto Rico, and has additional sales channels throughout South America, the Middle East, and Europe.

Position Summary:

  • Oversees all aspects of QC and R&D Chemistry Labs as directed.
  • Assists with additional work duties or responsibilities as evident or required.
  • Performs other duties as assigned or apparent. 

 

Primary Accountabilities:

 

NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbentsí performance objectives as outlined by the incumbentsí immediate supervisor or manager. 

  • Plans, organizes, and manages resources on projects to assure      technical and regulatory quality, budget and      schedule adherence.  
  • Oversee Quality Control Laboratories and assure operations are conducted in      accordance with regulatory requirements and expectations.  
  • Responsible for drafting SOPs related to Quality Control and      Research and Development functions, equipment, documentation, and/or      processes.
  • Develop and approve methods and results including:       product specifications; protocols, SOPs, and reports for analytical      method validation and stability studies; IQ/OQ/PQ protocols and reports      for equipment; master production records.  
  • Assists staff in developing solutions to complex technical and regulatory problems and investigation of unexpected results.  Participate in client and regulatory audits of facilities and quality system.  
  • Capable of defining strategic objectives for the R&D department as well as generating and implementing initiatives that improve the department efficiency and the quality of the results.

Knowledge, Skills & Abilities: 

  • Minimum Bachelorís degree and/or 10 years of experience working in Quality Control Chemistry and/or Research & Development.
  • Experience with cGMP documentation systems and with implementation of quality control systems.
  • Strong knowledge of FDA manufacturing/regulatory quality systems regulations, qualification, facilities and investigation requirements.
  • Must have strong project management skills and be able to provide technical vision and direction with compliance to standards in order to meet business initiatives.
  • Must possess direct experience in analytical method development, transfer and validation.
  • Must possess a strong experience base in product QC testing and release procedures and documentation.
  • Must be detailed oriented and have excellent organizational skills.              
  • Must possess effective written and oral communication skills and be able to handle multiple projects within limited time frames.
  • Must have skills in HPLC, GC, and mass spectroscopy detection  technologies.
  • Must have excellent communication and technical writing skills  
  • Expected to be a leader in the technology area and to train      others for more routine and specific project-oriented applications.
  •  The ability and willingness to change direction and focus to meet shifting organizational and business demands.
  •  The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
  •  The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
  •  The ability to manage a multitude of resources and to be accurate and current with data and information.
  •  The ability to create new products and processes that add value to the business, by generating new ideas and applying creative and analytical approaches.
  •  Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (10%), walking, and hearing.
  • 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.

 

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