Description

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, suspensions, injectables, and ophthalmics. 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 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:

• Oversee end-to-end BFS (Blow-Fill-Seal) and aseptic production processes to ensure efficient, safe, and compliant product manufacturing.

• Ensure full adherence to FDA 503B requirements and cGMP standards across all production activities.

• Lead and develop a high-performing production team while promoting a strong culture of quality, safety, and sterility assurance.

• Drive operational performance through effective resource planning, productivity management, and process optimization.

• Support continuous improvement initiatives to enhance throughput, reduce waste, and maintain audit readiness.

• Ensure production outputs meet quality standards, customer requirements, and business objectives.

Essential Duties and Responsibilities:

• Direct daily operations for BFS filling and aseptic compounding.

• Ensure production schedules, batch execution, and resource planning meet output, quality, safety, and service requirements.

• Maintain high operational performance through effective coordination with Quality, Supply Chain, Engineering, and Technical Services.

• Ensure all production activities adhere to FDA 503B Outsourcing Facility regulations, cGMP requirements, and internal SOPs.

• Maintain ongoing inspection readiness for FDA, state boards of pharmacy, and customer audits.

• Oversee the performance and efficiency of BFS equipment, tooling, and operating parameters.

• Support troubleshooting, preventive maintenance, and equipment optimization in partnership with applicable departments. 

• Ensure timely and accurate documentation, including batch records, logbooks, and equipment records.

• Support investigation of deviations and equipment failures; ensure effective CAPA implementation.

• Uphold strict data integrity standards across all production activities.

• Drive process optimization, waste reduction, and material flow improvements across BFS and aseptic areas.

• Plans, monitors, and analyzes key metrics for day-to-day operations to ensure efficient and timely completion of tasks. 

• Provides leadership and mentors production personnel, fostering a high-performing, cross-functional team and culture of continuous improvement, accountability, and operational excellence.

• Promotes a strong quality mindset through leadership visibility, mentoring, and ownership of performance metrics. 

• Partners with executive leadership on growth strategy, capacity planning, and improvement efforts across the division. 

• Ensure compliance with applicable EH&S standards and facility safety policies.

• Promote strong aseptic discipline, contamination control practices, and cleanroom behavior.

• Performs any other duties as necessary or assigned.

Knowledge & Skills:

• Comprehensive understanding of FDA regulatory frameworks covering both 503B Outsourcing Facility requirements and cGMP operations, including 21 CFR Parts 210/211 and applicable guidance documents.

• Strong expertise in sterility assurance, aseptic processing, environmental monitoring, and contamination control strategies within sterile manufacturing. 

• Proficiency in compounding and sterile formulation processes, filtration, solution preparation, and material flow in classified environments.

• Experience with process validation and equipment qualification (IQ/OQ/PQ), media fills, cleaning validation, and lifecycle process management.

• Demonstrated success implementing Lean, Six Sigma, and operational excellence initiatives to improve efficiency, yields, and throughput.

• Strong leadership capabilities with experience coaching and developing high-performing teams across operations, quality, and engineering functions.

• Prior experience supporting regulatory inspections (FDA, state board of pharmacy, or third-party audits).

• Must be detailed oriented and have excellent organizational skills.

• Must have excellent communication and technical writing skills.

Education/Experience: 

• Bachelor's degree in Engineering, Life Sciences, Pharmacy, Chemistry, or a related scientific/technical discipline required.

• Advanced degree (MBA, MS, MEng, PharmD, or equivalent) preferred.

• 10+ years of sterile pharmaceutical manufacturing experience in cGMP environments, with progressive leadership responsibilities.

• Direct experience in GMP manufacturing, including familiarity with regulatory expectations, validation requirements, and quality system standards.

• 5+ years of supervisory or management experience leading production teams in aseptic or BFS operations.

• In-depth knowledge of pharmaceutical compounding processes, regulations, and industry best practices. 

• Experience with cGMP documentation systems and with implementation of quality control systems. 

• Preferred experience in Six-Sigma and Lean Manufacturing methodologies.  

• Salary Range: Based on experience

Working Conditions / Physical Requirements:

• Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (10%), 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.

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