Nephron Pharmaceuticals

Nephron Pharmaceuticals Description:   Job Purpose:  Microbiology Quality Investigators ensure compliance with FDA regulations in the areas of microbiology-related investigations. Microbiology Quality Investigators are responsible for ensuring the Microbiology department’s adherence to FDA regulations. This involves completion of non-conformance investigations, the drafting of pertinent memorandums, managing deviations, and implementing robust corrective and preventive actions (CAPAs). A key aspect of the role is effective inter-departmental collaboration to facilitate the timely completion of all projects. Furthermore, investigators must skillfully manage their individual workload and adapt to shifting priorities to meet departmental and company demands.            Essential Duties and Responsibilities: Effectively completes microbiology excursion reports and associated documentation per procedure within specified      timelines.  Executes timely completion of CAPAs,...

Nephron Pharmaceuticals Description:    Job Summary:  The Environmental Regulatory Coordinator’s responsibilities serves to bridge the gap between complex scientific operations and legal requirements by ensuring compliance with environmental regulations, company policies, and supporting sustainability initiatives. This role supports our ability to monitor environmental performance, manage waste programs, maintain records, and assist with audits and reporting to promote environmental stewardship and regulatory compliance.          Primary Responsibilities: · Understand all applicable local, state, and federal environmental regulations pertaining to pharmaceutical manufacturing so as to ensure compliance.  · Coordinate the proper handling, storage, and disposal of hazardous, non-hazardous, biohazardous and other manufacturing waste.  · Maintain accurate environmental records, including waste manifests, permits, and inspection logs.  · Assist in preparing and submitting...

Nephron Pharmaceuticals Description:    Job Purpose:  · Ability to learn and perform Document Control functions.  · Provide support for the Quality Management System.  · Create and maintain standard operating procedures, change control records, and documentation in accordance with cGMP while assisting as needed in any aspect of the document control process. · Utilization of Laboratory Information Management System (LabVantage), SharePoint, and DOT Compliance software systems.  · Prepare and verify electronic and paper batch records. · Requires copying, filing, and scanning.  · Organization and time management techniques using tools like Microsoft Outlook calendar, reminders, and task lists.  · Assists with additional work duties or responsibilities as evident or required. · Flexibility to work overtime and weekends, if required.          Essential Duties and Responsibilities: NOTE: The primary accountabilities below are intended to describe the general content...

Nephron Pharmaceuticals 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...

Nephron Pharmaceuticals Description:    Job Purpose:  Senior Manager of Engineering to lead and oversee engineering activities across drug development and manufacturing operations. This role will be responsible for driving capital projects, ensuring compliance with GMP regulations, optimizing manufacturing processes, and supporting the scale-up of drug products from development through commercial production. The ideal candidate has a strong background in pharmaceutical engineering, cross-functional leadership, and regulatory compliance within a GMP environment. Essential Duties and Responsibilities: Lead and manage engineering teams supporting pharmaceutical process development, technology transfer, and commercial manufacturing. Oversee the design, installation, commissioning, and qualification (CQV) of equipment, utilities, and facilities used in drug development and production. Drive capital projects, including budgeting, scheduling, and vendor management....

Nephron Pharmaceuticals Description:    Job Purpose: The Metrology & Calibration Technician executes in-house calibrations, routine verifications, and diagnostics on critical manufacturing/instrument monitoring systems within a regulated cGMP drug facility. This role maintains the qualified state of production assets to ensure equipment accuracy and minimize downtime. Key responsibilities include managing scheduled calibrations for Blow-Fill-Seal (BFS) aseptic packaging systems and critical instruments ranging from environmental sensors to weight and pressure systems. All activities must strictly comply with cGMP standards, NIST traceability guidelines, and internal SOPs.       Essential Duties and Responsibilities: Instrument Calibration: Performs in-house scheduled and unscheduled calibrations on critical instrumentation, and equipment monitoring devices that affect product quality including temperature and humidity controllers, autoclaves, pressure transducers,...

Nephron Pharmaceuticals Description:   Job Purpose: Manage 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. Implement practical process improvements to reduce sample lead times and improve turn-around times for lab testing. Recruit, train, manage, and mentor direct reports. Maintain a flexible organization to allow fast changing manufacturing priorities to occur with minimum disruption and avoid back logs.  Ensure the Quality Control group is fully compliant with all cGMP requirements including adequate maintenance and cleanliness of equipment and laboratories. · Ensures the quality of laboratory operations and analytical testing meets or exceeds industry standards. Performs other duties as assigned or apparent. Essential Duties and Responsibilities: Plans, organizes, and manages resources on projects to assure technical and regulatory quality,...

Nephron Pharmaceuticals Description:    Job Purpose:  The Senior Engineering Associate provides technical and engineering support to the Manufacturing Science & Technology (MS&T) group, with primary responsibility for maintaining and controlling facility and engineering CAD drawings, supporting cleanroom construction activities, and assisting with capital and site improvement projects. This role serves as a key resource for engineering documentation, facility modifications, equipment installations, and project execution while ensuring compliance with cGMP requirements and internal quality standards. The position collaborates closely with Engineering, Validation, Quality, Manufacturing, and external contractors to support facility reliability, expansion initiatives, and operational excellence. Essential Duties and Responsibilities:    · Maintain, revise, and control facility, utility, process, and equipment CAD drawings in accordance with document control...

Nephron Pharmaceuticals Description:    QC Microbiology Technical Manager provides oversight of the day-to-day technical operations of Microbiology department, including but not limited to capacity planning, protocol development, process changes, data evaluation, and resource management in a high-growth, fast-paced, dynamic work environment while ensuring compliance with FDA regulations. Leads microbiology projects and process improvements, including Microbiology Protocols, Media Fill receipt and evaluations, investigations, personnel training, Compliance and Regulatory items, and any other special projects as required.        Essential Duties and Responsibilities: Provides technical leadership for the Microbiology team to ensure regulatory requirements are met. Leads capacity planning initiatives for Microbiology; this includes developing and/or reviewing new equipment resourcing, writing and reviewing new processes for onboarding new cleanroom suites, equipment,...

Nephron Pharmaceuticals Description:    Job Purpose:  The QC Microbiology Analyst I performs microbiology department related raw material, in-process, and finished product testing according to USP methods and established procedures that follow cGMP guidelines and demonstrate outstanding aseptic techniques. Must demonstrate a high level of proficiency in Microbiology testing.          Essential Duties and Responsibilities: · Applies quality scientific techniques in the microbiological analysis of raw materials; in-process & finished product samples to include: sterility, bioburden, identification, environmental monitoring, growth promotion, microbial recovery and media fill tests following approved procedures.  · Notifies Microbiology management of all OOS and OAL testing results.  · Provides feedback on SOPs, forms, logbooks, etc., as necessary, to facility ever-changing expectations for operating procedures and testing-related information.   · Performs routine...

Nephron Pharmaceuticals Description:    • Perform research and development projects for established products and new products including but not limited to analytical test method validation/transfer/verification, deformulation, procedures, investigations, and other non-specified projects or initiatives.  • Plans, organizes, and manages resources on projects to assure technical quality and schedule adherence  Performs other duties as assigned or apparent    Essential Duties and Responsibilities: • Capable of working in a GMP environment and responsible for generating GMP data.  • Capable of working with different analytical techniques including but not limited to HPLC, UPLC,  GC, Automatic Titrator, IR, DSC, ICP, and Mass Spectrometry.  4500 12th Street Extension, West Columbia, SC 29172 • Phone: 800.443.4313 • Fax: 803.926.9853 • nephronpharm.com  • Responsible for performing different analytical tests for R&D and QC as needed.  • Responsible for executing...

Nephron Pharmaceuticals Description:    Job Purpose: The purpose of this position is to support quality control testing and research and development activities as needed by conducting routine laboratory testing for raw materials, in-process materials, finished product, and stability samples in accordance with approved analytical methods.            Essential Duties and Responsibilities: Conduct routine laboratory testing for raw materials, in-process materials and samples, finished product samples, and stability samples in accordance with approved analytical methods.  Conduct and execute laboratory work and testing using best-practice analytical techniques and follow laboratory GDP and cGMP requirements Accurately analyze and interpret data using appropriate specifications and test methods.  Accurately peer review notebooks and verify raw data to support sample release, including data generated in electronic software systems. Accurately enter data using appropriate...

Nephron Pharmaceuticals Description:    Job Purpose: The purpose of this position is to support quality control testing and research and development activities as needed by conducting laboratory testing for raw materials, in-process materials, finished product, and stability samples in accordance with approved analytical methods.           Essential Duties and Responsibilities: Conduct routine and complex laboratory testing for raw materials, in-process materials and samples, finished product samples, and stability samples in accordance with approved analytical methods.  Conduct and execute laboratory work and testing using best-practice analytical techniques and follow laboratory GDP and cGMP requirements Accurately analyze and interpret data using appropriate specifications and test methods.  Accurately peer review notebooks and verify raw data to support sample release, including data generated in electronic software systems. Accurately enter data using...

Nephron Pharmaceuticals Description: The purpose of the Batch Record Review (BRR) role is to ensure that all manufacturing and packaging processes comply with regulatory standards, company policies, and quality requirements before product release. This role plays a critical part in maintaining product integrity, patient safety, and regulatory compliance by verifying that production records are complete, accurate, and meet Current Good Manufacturing Practices (cGMP) and other industry regulations (e.g., FDA, ISO).  By meticulously reviewing batch documentation, identifying deviations, and ensuring corrective actions are taken, the BRR role helps prevent product defects, recalls, and compliance issues, ultimately safeguarding public health and maintaining company credibility.     Essential Duties and Responsibilities: Oversee status of batches through disposition/release process and remove barriers, communicate escalations as appropriate. Performs final batch disposition...