Nephron Pharmaceuticals

Nephron Pharmaceuticals Description: This position will be responsible for ensuring the efficient design, optimization, and maintenance of manufacturing systems and processes to meet quality, safety, and regulatory standards. This role plays a key part in driving continuous improvement in production operations, working closely with cross-functional teams to enhance production efficiency, reduce costs, and maintain product quality.     Essential Duties and Responsibilities: · Team member and subject matter expert on cross functional team to develop Process Development Studies. Responsible for protocol generation and summary analysis of results for process changes or new products. · Team member and subject matter expert for the design and implementation of new equipment and equipment modifications to help improve safety, Quality, reliability, and throughput. · Responsible for implementation of new processes while maintaining cGMP compliance. · Team member and subject...

Nephron Pharmaceuticals Description:  The Vice President, Special Projects – Manufacturing Science & Technology (MS&T) is a senior leadership role responsible for driving high-impact, cross-functional initiatives across the pharmaceutical manufacturing network. This position leads strategic projects that enhance process robustness, accelerate technology adoption, and improve operational performance across commercial and R&D manufacturing. The role partners closely with Manufacturing, Quality, Supply Chain, and R&D to execute critical initiatives including process transfers, capital projects, special projects, and implementation of advanced manufacturing technologies     Essential Duties and Responsibilities: · Lead and execute high-priority, cross-functional special projects across Manufacturing Science & Technology (MS&T), ensuring alignment with corporate strategy and operational goals  · Serve as a key decision-maker and escalation point for...

Nephron Pharmaceuticals Description:  Quality Operations Clean Room Technicians Tier I are to monitor filling operations in compliance with company policies and Standard Operating Procedures, as well as FDA and cGMP regulations. Qualified individuals will be responsible to ensure the accuracy and completeness of batch records, and perform personnel monitoring, general operations filling in manual hoods, and other duties as necessary. Technicians will assist with additional work duties or responsibilities as evident or required.    Essential Duties and Responsibilities:  · Monitors aseptic techniques of personnel within the clean room. · Monitor Outsourcing filling operations within the clean rooms. · Verifies syringe filling rejects of Outsourcing products and performs quality attribute inspections as needed. · Maintains quality assurance documentation.    · Review/sign appropriate sections designated for Pharmacist/QA designee signatures within the batch records. ·...

Nephron Pharmaceuticals Description:    Tier 1 – Formulation Technician I (Entry-Level) Adherence to safety protocols and proper use of PPE. Adherence to Good Documentation Practices and Current Good Manufacturing Practice regulations. Complete and maintain applicable training certifications. Proper time management, including arriving on time, observing appropriate breaks – including lunches – as well as minimizing overtime unless authorized by management. Any deviation from the assigned schedule must be communicated to management, including call-outs. Complete assigned tasks on production schedule in an efficient manner. Complete dispensing, formulation, filter integrity testing, sample submission and all other supporting processes per applicable batch records, procedures, or forms. Ability to properly enter cleanrooms, maintain gown certification requirements, and demonstrate proper cleanroom environment behavior – such aseptic technique. Operate and navigate...

Nephron Pharmaceuticals Description:    Job Purpose: The Sterile Room Technician supports aseptic manufacturing operations in a controlled cleanroom environment, ensuring the production of sterile pharmaceutical products in compliance with GMP, SOPs, and regulatory requirements. The position is tiered into three levels based on experience, skills, and independent decision-making authority. Essential Duties and Responsibilities:  Tier I – Entry Technician  Perform basic aseptic gowning and maintain cleanroom discipline in ISO 5–ISO 8 areas. Assist in material and component preparation, staging, and transfer into cleanroom. Clean and sanitize production equipment and classified areas per SOPs. Support line set-up under close supervision. Perform basic in-process checks (e.g., environmental monitoring plate placement, line clearance). Accurately complete batch records and logbooks with guidance. Identify and report deviations or potential contamination risks...

Nephron Pharmaceuticals Description:    Job Purpose:  The Quality Engineer supports aseptic manufacturing operations by executing quality system activities, participating in facility and equipment commissioning, and driving process improvements. This role works cross-functionally with Manufacturing, Engineering, MS&T, and Quality to ensure compliance with cGMP requirements while supporting both development and commercial manufacturing programs. This position includes hands-on involvement in cleanroom environments and requires strong technical, analytical, and documentation skills. Essential Duties and Responsibilities: · Execute and support cGMP operations and project-based work, including commissioning activities, process studies, and quality system initiatives  · Participate directly in facility and equipment commissioning activities, including field execution, documentation, and coordination with engineering and operations teams  · Support and execute...

Nephron Pharmaceuticals Description:    Job Purpose:  Basic level of understanding the manual packaging processes and necessary preparation, able to participate in all steps of the manual packaging process as well as the ability to assist packaging machines when accompanied by an experienced technician. Provides support to packaging operations as needed.       Essential Duties and Responsibilities: Prepare production components for packaging activities. Sanitize and inspect materials. Perform packaging operations consistent with established protocols, procedures, and cGMP requirements.  Performs visual inspections of Outsourcing products if deemed necessary or required. Assist in inventory control and stocking of supplies. Assist with housekeeping and maintenance as appropriate or required. Maintain proper documentation of all packaging activities consistent with established GDP policies and procedures. Assist with the review of operational procedures as...

Nephron Pharmaceuticals Description:    Job Purpose:  To assist with the entire payroll process to ensure employees are paid accurately and on time, while also guaranteeing compliance with all relevant laws and tax regulations. Key duties include managing payroll systems, ensuring accurate tax withholdings and deductions, and collaborating with HR and finance/ accounting departments.       Essential Duties and Responsibilities: · Accurately prepare, complete and maintain payroll using Paylocity payroll system for both exempt and non-exempt employees. · Review personnel time cards to ensure compliance with Federal and State regulatory requirements and Nephron’s policies and procedures. · Respond to employee inquiries regarding payroll matters, e.g. time off requests, payroll and tax forms, etc. · Assist with quarterly payroll tax, year-end payroll and W-2 reconciliations. · Prepares reports from Paylocity as needed by approved members of Management. · Conducts...

Nephron Pharmaceuticals Description:      Job Purpose:  Serves as the Operations Associate for Manufacturing Operations and provides direct support to the Executive Vice President of Manufacturing Operations, Vice President of Manufacturing BFS and their direct reports.  Oversees day-to-day functions with the development and implementation of efficient coordination of office management, ensuring an effective office environment. Develop and implement project plans, processes, and systems to ensure timely project completion. Successfully manage project timelines, resources and deliverables and present regularly to upper management. Responsible for assisting with tracking and trending data related to operations. _________________________________________________________________________________________ Essential Duties and Responsibilities:  Responsible for providing project management and administrative support to the BFS Area Acts as Author for Document Change...

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...

Nephron Pharmaceuticals Description:    Job Purpose:  Performs Quality Attribute Inspections of the product through the packaging process in compliance with company policies/procedures, FDA and cGMP regulations.  Ensures the accuracy and completeness of batch records.   Performs other duties as assigned or apparent.   Essential Duties and Responsibilities:  Review Batch Records and applicable documentation to ensure complete, thorough and accurate data.  Responsible for ensuring a high level of employee accountability and performance.  Maintains quality assurance documentation including shift pass downs.   Keep QA work station clean and orderly.   Perform packaging line clearances.  Pull Retain, Stability, and Lab samples.  Perform or verify Quality Finished Product Attribute Inspections.  Perform AQL Calculations.  Verify component Exhibits  Verify all documents are present within the batch record.  Support validation and manufacturing studies,...

Nephron Pharmaceuticals Description:    Job Purpose:  The Quality Operations Materials Management Specialist is responsible for the inspection, sampling, and disposition of any specified raw materials, production components, and resin. Specialists work with other departments to ensure receipt, sampling, and releases are within compliance and completed in a timely manner. Qualified personnel will use Nephron’s electronic inventory system and complete all corresponding documentation to ensure compliance with regulatory standards.           Essential Duties and Responsibilities: Perform quality checks on incoming raw materials, production components, and resin to ensure to ensure documentation and information on containers is accurate and complete. Oversee the disposition of raw materials, production components, and resin.  Collect samples for incoming inspection based on MIL-STD 105E/ANSI/ASQ Z1.4. Utilize approved sampling supplies and inspection tools to collect...

Nephron Pharmaceuticals Description: QC Chemistry Sample Management Coordinators are to manage the receipt, storage, organization, and disposal of Analytical Services laboratory samples in a high-growth, fast-paced, dynamic work environment while ensuring compliance with FDA and DEA regulations. The qualified individual will be responsible for receiving and logging samples into the company’s Laboratory Information Management System (LIMS) while ensuring compliance of QC practices. The qualified individual will assist in maintaining a flexible organization to allow fast changing manufacturing priorities to occur with minimum disruption and avoid backlogs. The individual will assist with additional work duties or responsibilities as evident or required.    Essential Duties and Responsibilities: Receive and log samples in accordance with SOPs and GMP requirements through LIMS or other tracking systems. Distributes, bags, and labels samples according to required testing...

Nephron Pharmaceuticals Description:    Job Purpose: Responsible for coordinating with other departments including Calibration and Maintenance to ensure completion of required activities for implementation and maintenance of Formulation equipment. Coordinate and/or contribute to the completion of projects involving Formulation equipment.  Implement new initiatives to improve formulation production equipment. Participate in Dispensing and Formulation activities as needed by the Formulation department. Assist with additional work duties or responsibilities as evident or required. Essential Duties and Responsibilities: Proper communication with applicable departments such as Calibration and Maintenance. Operate and navigate software systems including but not limited to: LabVantage, PIMS, FactoryTalk, Trackwise, and EBR. Adherence to Good Documentation Practices and Current Good Manufacturing Practice regulations. Administrative responsibilities (Technical...