Director Of Quality Control Chemistry

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, 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. 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:

• This role will be responsible for all operational aspects of the Quality Control Analytical Services organization in support of method validation, raw material, in-process, release, and stability testing of drug products.
• Manage multiple      teams within the Analytical Services department to meet 24x7x365 manufacturing and laboratory schedules.
• Maintain a flexible organization to allow fast changing  manufacturing priorities to occur with minimum disruption and avoid back logs. 
• Ensure the Analytical Services group is fully compliant with all cGMP requirements including adequate maintenance and cleanliness of equipment and laboratories.
• 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 incumbents' performance objectives as outlined by the incumbents' immediate supervisor or manager.

• Oversee the day-to-day operations of the QC Chemistry      laboratory in a high-growth, fast-paced, dynamic work environment while      ensuring compliance with FDA and DEA regulations.
• Plans, organizes, and manages resources on projects to      assure technical and regulatory quality, budget, and schedule adherence.       
• Serve as a POC and Subject Matter Expert for Analytical      laboratory functions.
• Oversees analytical techniques, interpretations of      analytical data, problem solving and troubleshooting as required for AS      approval.
• Prepare SOPs, guidance, protocols, reports, to support      laboratory GMP function in compliance with FDA, ICH and other regulatory      guidance. 
• Ensuring employees are properly trained and qualified      to perform their assigned tasks, providing developmental feedback and      coaching, and supporting team career development.
• Implement practical process improvements to reduce lead      times and improve turn-around times for lab testing.
• Calibrate, maintain, and troubleshoot analytical equipment,      identify and purchase of new equipment as needed.
• Oversee the Operations of the Quality Control Chemistry      Laboratory and assure operations are conducted in accordance with      regulatory requirements and expectations.  
• Responsible for drafting SOPs related to Analytical      Services 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.  
• Direct, perform and resolve out-of-specification      investigations and implement corrective and preventative actions
• Capable of defining strategic objectives for the      Analytical Services department as well as generating and implementing      initiatives that improve the department efficiency and the quality of the      results. 
• 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 QC      Chemistry department as well as generating and implementing initiatives      that improve the department efficiency and the quality of the results. 
• Support all change control as it relates to lab      investigation CAPAs and laboratory process improvements. 
• Ensures internal procedures and methods are aligned to      create a high level of product quality and consistency, in accordance with      all internal and external regulations.
• Consistent collaboration with all department managers      to ensure that quality standards and GMP compliance are met and      maintained.

Knowledge, Skills & Abilities:

• Minimum      Bachelor's degree and 10 years of experience working in cGMP Chemistry laboratory.
• 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.
• Advanced      knowledge of cGMP, ISO, FDA, MHRA, USP, PDA, JP, and EP regulations and      guidelines as related to the manufacture of pharmaceutical products. 
• Must have strong      project management skills and be able to provide technical vision and      direction with compliance to standards 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 oneself, 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. 
• 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.