Nephron Pharmaceuticals jobs - 37 jobs

Apply Description Job Purpose: The Production Change Control Manager is responsible for overseeing and managing change control activities related to manufacturing operations, including production processes, equipment, facilities, materials, and associated documentation. This role ensures compliance with FDA regulations, cGMPs, and internal quality systems by evaluating the impact of proposed changes, implementing appropriate controls, and maintaining product quality, safety, and regulatory compliance. The Production Change Control Manager serves as a subject matter expert (SME) for change control within manufacturing and provides guidance to cross-functional teams to ensure changes are properly assessed, documented, approved, and implemented Essential Duties and Responsibilities: Manage and oversee production-related change control activities in accordance with FDA regulations, cGMPs, and company quality policies. Facilitate the review, coordination, and approval of change records related to manufacturing processes, equipment, facilities, materials, utilities, and production systems. Evaluate and facilitate review of proposed production changes to assess potential impact on product quality, process performance, validation status, regulatory filings, and compliance. Ensure all changes are thoroughly documented, including change requests, impact assessments, risk assessments, implementation plans, and effectiveness checks. Ensure change controls are appropriately linked to validation, qualification, calibration, maintenance, and training requirements, as applicable. Review controlled documents (SOPs, batch records, work instructions, forms, and labels) to ensure accuracy, completeness, and compliance with approved production changes. Participate in Change Review Board (CRB) meetings, including presentation of production change metrics, trends, and KPIs. Present quarterly change control trends and performance metrics at Quality Management Review (QMR) meetings. Investigate and resolve issues or delays related to change control approvals by collaborating with cross-functional stakeholders. Monitor the effectiveness of production change implementations and identify opportunities for process improvement. Ensure data integrity, traceability, and accuracy of all change control records. Support manufacturing initiatives, campaigns, and special projects requiring change control oversight. Communicate quality-related risks, issues, or noncompliance related to production changes to Quality Management or designee. Participate in continuous improvement efforts to enhance the efficiency and effectiveness of production change control processes. Perform other duties as assigned or required to support manufacturing and quality objectives. Supplemental Functions: Support and participate in customer, internal, and regulatory audits and inspections, specifically related to production change control. Educate and train manufacturing and support personnel on production change control procedures, documentation standards, and best practices. Conduct system access and change control training for new production and support employees. Periodically review production change control activities and metrics to identify trends, risks, and improvement opportunities. Job Specifications and Qualifications Knowledge & Skills: Strong technical background with solid knowledge of Quality Assurance, cGMPs, FDA regulations, and QMS-based change control systems. Hands-on experience managing production change controls within electronic Quality Management Systems (eQMS). Excellent written and verbal communication skills with strong interpersonal abilities. Strong analytical, critical-thinking, and problem-solving skills, with high attention to detail and data integrity. Ability to manage multiple priorities, meet deadlines, and perform effectively in a fast-paced manufacturing environment. Ability to work independently and collaboratively across cross-functional teams. Proficient in technical writing and use of Microsoft Word, Excel, and Adobe Acrobat. Demonstrates professionalism, integrity, and discretion in handling confidential quality and regulatory information. Education/Experience: · Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical discipline required. · Advanced degree or Quality/Regulatory certification (e.g., ASQ, CQE, CQA) preferred. · 5+years of experience in a regulated manufacturing environment (pharmaceutical, biotech, medical device, or related industry). · 3+ years of hands-on experience managing change control within a QMS or electronic QMS (eQMS). · Demonstrated experience evaluating changes to manufacturing processes, equipment, facilities, utilities, and materials. · Working knowledge of cGMP, FDA regulations, and quality systems governing production operations. · Experience supporting regulatory inspections, customer audits, and internal audits. · Proven ability to collaborate with Manufacturing, Engineering, Validation, Maintenance, and Quality teams. · Experience leading or participating in Change Review Boards (CRB) and presenting change control metrics or KPIs preferred. Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility. Willingness to change direction and focus to meet shifting organizational and business demands. Individual may require to wear specified protective equipment if necessary Hours of work: Monday thru Friday on 8 hours shift, or as needed based on company demand.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Interstitial Lung Disease (ILD) Sales Consultant is responsible for implementing the Boehringer Ingelheim ILD sales and marketing plans to assure maximum distribution and market penetration of Boehringer ILD products within Boehringer guidelines, policies and directives. The ILD Sales Consultant will conduct their business with key ILD Clinics and appropriate targeted Pulmonologist/Rheumatologist/Radiologist/Advanced Practice Clinicians and Allied Healthcare Professionals. The incumbent will have additional responsibilities for sales activities in teaching and community hospitals, federal and military hospitals. The Sales Consultant will manage a geography that may require overnight travel and occasional night and weekend ILD meeting responsibilities. Duties & Responsibilities Maintains and utilizes ILD product knowledge and highly effective selling skills to influence targeted ILD health care professionals to support the use of BIPI promoted products. Executes brand strategies and business plans to ensure a consistent company sales and marketing message. Establishes and maintains effective communication/cooperation/coordination with internal BIPI employees. Develops clinic and customer Pre-call plans and leverages company approved technology and resources, while utilizing questions that encourage dialogue to meet ILD health care professionals' (HCP) and account needs. Builds valued discussion around ILD HCP needs and opportunities. Has accurate and timely follow-up discussions with ILD HCP. Uses appropriate BIPI Sales Training techniques, supports and encourages exchange of scientific knowledge and dialogue thereby providing enhanced value and trust to the HCP through facilitation of patient management and decision-making process. Identifies key ILD business needs and activities, establishes business plans to address an ILD territory business need and actively involves Associate Director, Patient and Community Clinical Educators, Access and Reimbursement, Payer Relations Managers, and other company Internal support personnel in the development, management and accomplishment of business strategies, plans and opportunities. Demonstrates the ability to analyze territory information to optimize ILD HCP calls. Monitors and effectively reacts to local market conditions for changes that impact business. Develops plans to maximize Regional and National Speaker and other regional sales and marketing programs. Adjusts implementation plans on a regular basis (speaker development and management, advocate development, etc.) Creates opportunities that meet both territory and brand tactics. Utilizes sales data and supporting analysis to plan activity, monitors literature use, and maintains account and ILD HCP records. Completes all administrative responsibilities in a timely fashion as directed by management. Successfully completes all Sales Training requirements. Identifies and develops Regional and National ILD thought leaders, innovators and advocates to support BIPI ILD products. Provides appropriate feedback and follow-up to ILD speakers and attendees. Develops realistic plans to develop speakers and thought leaders. Initiates contacts and network-building among advocates and ILD HCPs. Manages programs and budgets to stay within company standards. Determines how to efficiently and effectively utilize Regional and National speakers and company resources by pro-actively working with Associate Director and Key Account Manager. Provides consistent, timely and complete administrative duties and responsibilities. Ensures all expense reports, call reports, and communications are completed effectively and on time. Accepts responsibility and ownership of personal development while working closely with associated ILD Associate Director. Develops a personal development plan and ensures twice annual review with Associate Director. Demonstrates a complete knowledge of BIPI ILD products and related marketplace, effective branded and unbranded sales presentations while remaining customer focused and solutions based. Requirements Candidate will be hired in at the level commensurate with experience: ILD Sales Consultant I Requirements • Bachelor's Degree required • A minimum of three (3) years of successful Pharmaceutical sales experience required; Two-plus (2+) years of Specialty/Pulmonary experience preferred. • Strong communications skills are required to perform the job satisfactorily. • Ability to translate key scientific information supporting product, competitors, science and marketplace to a broad range of ILD customers. • Ability to travel with overnights and attendance at some weekend programs. ILD Sales Consultant II Requirements • Bachelor's Degree from an accredited institution required. • A minimum of five (5) years of successful pharmaceutical sales experience with a minimum of three (3) years Specialty/Pulmonary experience required. • Strong communications skills are required to perform the job satisfactorily. • Ability to translate key scientific information supporting product, competitors, science and marketplace to a broad range of ILD customers. • Ability to travel with overnights and attendance at some weekend programs. Sr. ILD Sales Consultant Requirements • Bachelor's Degree from an accredited institution required • A minimum of seven to ten (7-10) years of successful Pharmaceutical sales experience with a minimum of five to seven (5-7) years Specialty/Pulmonary experience required. • Track record of working within a high performing team & a cross functional matrix environment. • Excellent communications, objective setting, and influencing skills. • Requires at least 1 year prior experience demonstrating acct. management, leveraging HUB services, collaborating with clinical educators & specialty pharmacies, supporting reimbursement navigation, working individually outside a "pod" structure, fostering market development, regional Key External Expert (KEE) engagement & relationship management, linking KEEs with appropriate internal stakeholders, fluency in the inner networking & navigation of teaching institutions • Ability to travel - overnight (inclusive of some weekend programs), approximately 10-50%, depending on geography. • Valid Driver's License and acceptable driving record • Proficiency in Excel, Word, Outlook, and any other relevant applications. • Strong communications skills are required to perform the job satisfactorily. • Ability to translate key scientific information supporting product, competitors, science and marketplace to a broad range of ILD customers. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. #LI-DG1

Apply 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, and has distributed over 1 billion doses of respiratory medication per year since 2009. 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: The Quality Systems Investigator is responsible for evaluating, investigating, and strengthening the company's Quality Management System to ensure compliance with pharmaceutical regulatory requirements and industry standards. This role leads and supports thorough investigations of deviations, complaints, and quality events; identifies root causes; and ensures effective corrective and preventive actions are implemented. By monitoring system performance, assessing process controls, and driving continuous improvement, the Quality Systems Investigator helps ensure the consistent manufacture of safe, effective, and high-quality products while maintaining regulatory readiness. Essential Duties and Responsibilities: • Responsible to assure compliance with FDA regulations in the areas of non-conformance investigations, planned deviations, or corrective and preventive actions (CAPA's) at Nephron Pharmaceuticals Corporation. • Responsible for assisting with tracking and trending data related to investigations. • Assists in developing and implementing project plans, processes, and systems to ensure timely project completion. • Assists with additional work duties or responsibilities as evident or required. • Performs other duties as assigned or apparent. Supplemental Functions: Manage investigations in an effort for timely completion, maintaining electronic files, updating procedures as required, etc. Maintains investigation files. Performs initial and secondary review of compliant investigations and ensures accuracy and completeness of records. Work collaboratively with quality investigations team with attention to repeated occurrences of similar root causes. Track and report investigation trends. Assist Continuous Improvement Quality Manager with areas of improvement and provide insight for Quality Improvement Plans (QIPs). Assist with the design and development of organizational training programs, tools, and processes to build quality. Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. Support all departments with investigations, complaints, audit response, process improvement and training for deviations and complaints as well as the subsequent Corrective and Preventative Actions (CAPAs). Reports any quality related issues to Director of Quality Assurance Investigations. Assist in other activities (as needed) for Quality Assurance management. Job Specifications and Qualifications: Knowledge & Skills: • Written and Oral communication skills. • Team Player, must be able to interact within the company with all departments. • Pharmaceutical experience with equipment, instrumentation, production, maintenance and engineering preferred. • Experience in Root Cause Analysis and technical writing skills required. • Specific expertise, skills and knowledge within Quality Assurance gained through education and experience. • A board perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities. • The ability to take strategic objectives and accept accountability to drive results through effective actions. • The ability and willingness to change direction and focus to meet shifting organizational and business demands. • The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business. • 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 take strategic objectives and accept accountability, motivate and influence others. Think globally, and leverages diversity. • The ability to manage a multitude of resources and to be accurate and current with data and information. • Position requires lifting (up to 40lbs), vision (20/20), standing (10%), walking (50%), talking, typing and hearing. • Incumbents required wearing specified protective equipment as necessary. • Salary range: Based on experience. • Hours of work: Monday through Friday on an 8-hour shift, or as needed based on company demands. Education/Experience: • Bachelor's degree with 3-5 years of pharmaceutical experience in Quality Systems preferred. • 1-3 years of experience with MS Word, Excel, and PowerPoint preferred. • 1-2 years project management and coordination experience preferred. Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility. 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.

The PCP/Endo Business Specialist is responsible for developing and implementing a plan for maximizing net sales of BIPI and co-promoted diabetes products that aligns with direction from BIPI commercial leadership and with BIPI guidelines, policies, and directives. The PCP/Endo Business Specialist will conduct their business with key targeted healthcare providers and community hospitals, and may have additional responsibilities in teaching hospitals, federal and military hospitals, managed health care facilities, group purchasing organizations, integrated delivery networks, etc. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities Utilizes product knowledge and demonstrated selling skills in order to influence targeted health care professionals to support the use of BIPI promoted diabetes products. Executes brand strategies to ensure that company sales and marketing messages are delivered appropriately to customers. Establishes and maintains effective communication/cooperation/coordination with co-promotion partners and BIPI employees. Completes pre-call plans to meet key stakeholder needs. Builds discussion around customer needs and opportunities. Fosters customer network development and communication. Has accurate and timely follow-up discussions with customers. Fosters ongoing trust with customer as relationship develops. Uses appropriate BIPI Sales Training techniques to facilitate the customer decision making process. Coordinates the engagement of healthcare providers through a range of personal and non-personal channels, according to customer preferences. Identifies top plans for customers. Engages customers in comprehensive discussions on the payer environment, co-pays, and formulary access. Works with Managed Care Area Managers to generate and sustain support for products on MCO formularies. Develops and influences an extended team to pull-through MCO decisions. Delivers on "continuation of care" model, including discharge protocol, treatment algorithms, disease management, etc. Analyzes qualitative and quantitative territory information to optimize territory business plan and customer calls. Monitors local market conditions for changes that impact business. Develops plans to optimize allocation of key resources, including samples, co-pay cards, funds for speaker programs, and funds for in-office meals. Adjusts implementation plans on a regular basis (speaker mgmt., advocate development, etc.). Leverages opportunities that meet both territory and brand tactics. Utilizes supporting analysis tools to plan activity, report and monitor resource utilization, and maintain account and customer records. Completes all administrative responsibilities as directed by management. Successfully completes all Sales Training requirements. Identifies thought leaders, innovators and advocates to support BIPI products. Works with trained speakers for diabetes topics and products. Provides feedback and follow-up to speakers and attendees. Initiates contacts and network-building among advocates and customer groups. Develops plans to develop speakers and thought leaders. Manages programs and budgets to stay within standards. Works effectively with all customer-facing roles (i.e. Account teams, Medical teams, etc.) in a given geography to meet customer needs and deliver net sales objectives. Demonstrates strong collaboration and communication as customers evolve and ownership of accounts transition from traditional to account based. Performs all Company business in accordance with all regulations (e.g., EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community. PCP/Endo Business Specialist Requirements Bachelor's degree from an accredited institution is preferred. A minimum of two (2) years successful sales and/or marketing experience in pharmaceutical/healthcare industry, pharmacy, B2B, customer engagement services or equivalent Experience in diabetes therapeutic area preferred. History of successful performance Meets expectations for the key competencies required for this role Proficiency in Excel, Word, Outlook, and database applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership. Valid Driver's License and an acceptable driving record Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. Physical Demands / Surroundings Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. Visual Demands Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. Temperaments/Mental Requirements Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. Level of Proficiency Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. “Export Laws” means the Export Administration Regulations (“EAR”) of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time. Executive PCP/Endo Business Specialist Requirements Bachelor's degree from an accredited institution preferred A minimum of five (5) years successful sales and/or marketing experience in pharmaceutical/healthcare industry, pharmacy, B2B, customer engagement services or equivalent Experience in diabetes therapeutic area preferred History of successful performance Meets expectations for the key competencies required for this role Proficiency in Excel, Word, Outlook, and database applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership. Valid Driver's License and an acceptable driving record Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. Physical Demands / Surroundings Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. Visual Demands Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. Temperaments/Mental Requirements Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. Level of Proficiency Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. “Export Laws” means the Export Administration Regulations (“EAR”) of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time

The Hygiene Associate is responsible for the planned and unplanned cleaning and sanitization of the clean manufacturing areas of the site in a timely manner. Work in these areas is performed while gowned, and persons in this position are not allowed to wear/use items such as jewelry, make-up, cologne, hair products, etc. Responsibilities: Practice excellent personal hygiene habits at all times. Perform planned and unplanned cleaning and sanitization activities as directed. Produce and maintain the required documentation in support of all cleaning and sanitization actions performed. Must be able to understand and implement the proper use of cleaning agents. Must report deviations from facility procedures to the Lead Hygiene Associate. Will be required to clean and sanitize areas contaminated by accident or other event, including blood born pathogens, and follow all required Standard Operating Procedures associated with such events. Follow all guidelines for the use of personal protection equipment as needed. Follow all Standard Operating Procedures, as well as all safety, health, and cGMP Guidelines. Will assist Housekeeping Associates with their job duties, including the sorting, stocking, and transporting of gowns and related gowning materials and supplies as required. Will assist Facilities Technicians as required. Must be able to utilize powered cleaning equipment as needed. Other duties as assigned. Qualifications: Ability to prioritize and implement tasks with minimal supervision. Strong interpersonal and group skills. Familiarity with basic computer skills. Must possess good oral and written communication skills. Clean room environment experience preferred but not required. Previous cleaning experience desired.

Apply Description Job Purpose: Secondary Packaging's main objective is to place primary packaged products into outer packaging that provides additional protection for distribution and retail. The secondary packaging process ensures the safe, compliant, and efficient transport of the pharmaceutical products. Essential Duties and Responsibilities: Monitor the operation of Secondary Packaging equipment to determine trends (i.e. vials per minute and pallets packaged per shift. Responsible for overseeing changeovers and end of lot procedures. Responsible for reconciliation in the MBR. Responsible for training new personnel on your shift. Responsible for starting, stopping and repairing minor problems with Secondary Packaging equipment. Initiate and manage any document, equipment, or process change related to non-conformance investigations as corrective/preventive action. Coordinate training sessions on new documents or processes. Ensure completion and implementation of CAPAs (corrective/preventive actions). Coordinate and update the daily packaging schedule in the absence of the Operations Manager. Initiate, create, and manage any document, equipment, or process change as delegated by Operations management. Writes or reviews manufacturing procedures and related document. Prepare and review internal documentations for management and production staff. Participates in internal GMP audits and supports customer and regulatory audit response. Assists with additional work duties or responsibilities as evident or required. Performs other duties as assigned or apparent. Supplemental Functions: · Work under the direction of the Director or designee. · Assure the efficient performance of all department equipment. · Assist with housekeeping as needed. · Adhere to GMPs and hold those around them accountable. Job Specifications and Qualifications: Knowledge & Skills: Knowledge of the Pharmaceutical of Manufacturing Industry preferred. Must be able to pass a Drug Test. Must speak, write, and read English. Specific expertise, skills and knowledge gained through education and experience. Ability to take strategic objectives and accept accountability to drive results through effective actions. Ability and willingness to change direction and focus to meet shifting organizational and business demands. Ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. Ability to create new products and processes that add value to the business by generating new ideas, applying creative, and analytical approaches. Ability to prioritize tasks, manage time efficiently, and meet deadlines. Familiar with relevant industry regulations and compliance standards. Incumbents required to wear safety glasses, hearing protection and other non-specified protective equipment as necessary. Strong critical thinking, analytical, problem-solving, and interpersonal skills. Strong organizational skills with the ability to manage multiple projects or assignments simultaneously. Education/Experience: High school diploma or equivalency is required. Prefer 2yrs of manufacturing or pharmaceutical experience but not required. Working Conditions / Physical Requirements: This position requires lifting (up to 50lbs), bending, climbing, reaching, good vision, standing, sitting, walking, gripping, talking, and hearing.

Apply Description Job Purpose: 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 of finished drug product and combination product batches, to ensure high quality medicine (cGMP Compliance) is released within expected metrics to ensure timely release to market. Performs review checklist to verify all requirements have been performed and meet requirements. Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices (GDP). Review documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices, including but not limited to executed batch records, master batch records, and product specific documents. Independently executes batch record review for completeness, accuracy and cGMP compliance. Support the evaluation and lot disposition of drug product. Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and Standard Operating Procedures (SOPs). Contributes to process improvement of batch records and associated processes (e.g. turnaround times) to ensure all Quality Assurance (QA) batch disposition deadlines are met. Responsible for the review and approval of cGMP documentation against SOPs in order to ensure compliance in Manufacturing processes. Raise deviations as needed in order to capture potential impacts to product quality. Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management. Work with colleagues to instill a sense of ownership and commitment to quality. Provide technical support to the leadership team in the decision-making process. Supplemental Functions: · Performs and maintains archiving of all batch documentation to include copying, scanning, and filing. Revise or review standard operating procedures and submit procedural changes as needed to meet local, Global and Regulatory requirements. Keep abreast of industry developments, forthcoming regulations, guidance, best practices, etc for all Scientific Areas. Performs and assists with additional work duties or responsibilities as assigned or apparent. Job Specifications and Qualifications: Knowledge & Skills: Comprehensive knowledge of quality system requirements such as US FDA, cGMP, GCP, EMA, and ICH guidelines and has a proven track record of successfully implementing these requirements to ensure patient safety and compliance with FDA and other applicable health authorities' requirements. Competent in Microsoft Word and Excel. Knowledgeable in Adobe Acrobat (PDF) advanced features and workflows. Familiar with document management software, including SharePoint. Excellent written and oral communication skills. Team player and must be able to interact with all departments. Ability to work independently and be dependable. Technical writing skills required. Strong attention to detail. Specific expertise, skills, and knowledge within Quality Assurance gained through education and experience. The ability and willingness to change direction and focus to meet shifting organizational and business demands. The ability to create and contribute to an 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. Education/Experience: BS degree preferred with at least 1 year of experience in a regulated cGMP Environment. In lieu of degree, at least 4 years of equivalent experience in pharma manufacturing operations considered and strong background in GDP. Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 40 1bs.), vision (20/20). Standing (10%), sitting (80%) and walking (10%) throughout the facility.

Apply Description Job Purpose: Secondary Packaging's main objective is to place primary packaged products into outer packaging that provides additional protection for distribution and retail. The secondary packaging process ensures the safe, compliant, and efficient transport of the pharmaceutical products. Essential Duties and Responsibilities: · Operate the Secondary Packaging equipment and determine trends (i.e. vials per minute and pallets packaged per shift). · Responsible for changeovers and end of lot procedures. · Responsible for documenting in the MBR. · Responsible for operating and repairing minor problems with Secondary Packaging equipment. · Responsible for clearing machine jams and minor adjustments. · Perform line clearances, machine challenges, exhibits, and startup checklist. · Perform cleaning, vacuuming, and other housekeeping duties to maintain a high level of cleanliness of the Secondary Packaging lines. · Be trained on, and able to clear minor problems on all packaging lines. · Be familiar with Autoclave process. · Be familiar with Laser Guided Vehicles (LGVs) and know how to clear faults. · Monitor waste and make adjustments to product placement as needed. Be able to maintain pouch appearance accordingly. · Verify lot number and expiration dates are correct. Ensure labeling is neat and correctly placed on all products. · Follow the instructions of the paper Master Batch Record or the Electronic Batch Record. · Read and understand all Standard Operating Procedures for the tasks you are performing. · Perform additional work duties or responsibilities as evident or required. Supplemental Functions: . Education/Experience: High school diploma or equivalency is required. Prefer 1yr of manufacturing or pharmaceutical experience but not required. Working Conditions / Physical Requirements: Position requires lifting (up to 50lbs), bending, climbing, reaching, good vision, standing, sitting, walking, gripping, talking, and hearing.

The Microbiologist I is responsible for all duties related to performing environmental monitoring, personnel monitoring, microbial enumeration, microbial identification, and sampling of utilities. The Microbiologist I is also responsible for performing all the microbiological testing related to raw materials, utilities, and in-process product testing. Other responsibilities include data entry, data review, ensuring calibration of equipment, maintaining and ordering inventory of laboratory supplies, and maintaining the Microbiology laboratory by ensuring its cleanliness and order. Please note that the scheduled shift for this position will be 7PM-5:30AM, with rotating weekends. Level 1 - Less than 12 months experience or no experience - Environmental Monitoring Completion - Utilities completion - Microbial Identification (subculture, Gram-stain, ID entry, VITEK MS assist) and enumeration - Raw Material Testing including APIs Responsibilities: Responsible for performing all microbiological testing of raw materials, utilities, and in-process, and final products/stability (as applicable) for commercial and method development. Responsible for performing daily, weekly, semi-weekly, and monthly environmental monitoring of the manufacturing environment and other areas. Responsible for performing enumeration, organism identification including culturing, isolating, entry, and maintaining of organisms. Document and review of raw and final data to ensure complete and proper documentation according to procedures and applicable cGMPs. Notify Microbiology Laboratory management immediately of out of specification (OOS) results. Responsible for routine maintenance and preventative maintenance of laboratory equipment. Notify Microbiology Laboratory management of laboratory equipment problems or calibration issues. Responsible for reviewing and entering microbiological data into finished product batch records and other applicable laboratory documents (i.e. laboratory notebooks). Document and review of raw and final data to ensure complete and proper documentation according per procedures and applicable cGMPs. Responsible for maintaining and entering microbiological data (including Identification) into the Quality database and ensuring all data has been entered by review. Responsible for assisting with investigations for environmental monitoring excursions (action/alert level investigations), deviations, and OOS results as requested by the Microbiology Laboratory management. Responsible for the general maintenance and cleaning of the Microbiology Laboratory (including identification and warehouse areas) including good housekeeping and a safe working environment. Responsible for temperature monitoring, maintenance, and notification of calibration of laboratory equipment. Assist in regulatory audits as requested by Microbiology Laboratory Management. Assist in training of new employees on all applicable SOPs and tasks. Responsible for assisting with ordering and maintaining inventory of laboratory supplies including organization, labeling, and discard of materials. With guidance from Microbiology Laboratory management, assist in review of SOPs. Follow Standard Operating Procedures, safety, health, and cGMP Guidelines. Qualifications B.S. degree in Microbiology or related field. Minimum 0 - 1 year experience. Ability to understand/follow all applicable standard operating procedures and cGMPs routinely. Proficient with current word processing, spreadsheets, and database software. Demonstrated knowledge of standard laboratory techniques and procedures as evidenced by prior work experience or on the job training. Ability to operate standard and advanced laboratory instrumentation as evidenced by prior work experience or on the job training. Ability to participate in and contribute to a team-oriented work environment by developing positive working relationships within quality organization and between other departments.

Apply Description Job Purpose: 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. · Promotes teamwork both within the QA Team and other departments. · Monitors all filling areas and personnel for adherence to all cGMP, SOP's and safety regulations. · Keep line and work station clean and orderly to ensure no product line contamination. · Perform line clearance including equipment, components and label verification. · Perform room releases for filling rooms for Outsourcing areas. · Communicate quality - related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor/Management. · Review all completed production batch record documentation to ensure completion and compliance. · Reviewing Logbooks for GDP and accuracy. · Performs general operation QA functions for manual filling processes. · Ability to perform personnel monitoring within the clean room. · Trained and authorized to enter samples into LabVantage. Supplemental Functions: · Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations. · Assist with development of solutions for chronic problems within quality assurance · Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management. · Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. · Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. · Assist in other activities (as needed) for Quality Assurance management. Knowledge & Skills: · Detail oriented. · Good computer skills in MS Outlook, MS Word, MS Excel, Internet, Email and basic typing skills. · Good visual acuity and observation skills. · Good written, oral and comprehensive communication skills. · Able to handle diversity of projects. · Specific expertise, skills and knowledge within quality assurance gained through education and experience. · A board perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities. · 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. · Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary. Education/Experience: · High School Diploma or GED · Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of GMP preferred. Working Conditions / Physical Requirements: · Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25lbs), reaching (waist to head), vision (20/20), standing (40%), sitting (20%), walking (40%), typing and hearing.

Apply Description Job Purpose: The Sterile Filling Technician is responsible for performing aseptic filling and related sterile operations within a 503B outsourcing pharmaceutical manufacturing facility. This role ensures products are prepared, filled, and packaged in compliance with FDA 503B regulations, cGMP standards, and company SOPs to ensure product quality and patient safety. __________________________________________________________________________________________ Essential Duties and Responsibilities: Sterile Filling & Operations Ø Perform aseptic filling of injectable pharmaceuticals in cleanroom environments (ISO 5, ISO 7). Ø Operate and monitor sterile filling equipment (e.g., filling machines, cappers, and autoclaves). Ø Conduct manual and automated sterile filling processes according to batch records and SOPs. Ø Support environmental monitoring by maintaining strict aseptic technique. Ø Participate in line clearance, equipment set-up, in-process checks, and end-of-run reconciliation. Compliance & Documentation Ø Complete all batch records, logbooks, and electronic documentation in real time and with accuracy. Ø Adhere to FDA 503B regulations, cGMP, and internal quality policies. Ø Report deviations, non-conformances, or potential quality issues to supervision immediately. Ø Support regulatory inspections and internal audits as needed. Cleanroom & Equipment Maintenance Ø Follow gowning procedures and aseptic practices required for sterile areas. Ø Assist in cleaning, sanitizing, and maintaining cleanroom areas and equipment. Ø Perform equipment setup, operation, and minor troubleshooting under supervision. Teamwork & Continuous Improvement Ø Work collaboratively with Production Scheduling, Sterile Room, Quality, Microbiology, Engineering, and other Manufacturing teams to ensure smooth sterile production runs. Ø Participate in ongoing training programs to maintain qualifications for cleanroom operations. Ø Suggest process improvements to enhance efficiency, safety, and compliance. Supplemental Functions: Ø Performs all other duties as assigned or apparent. Job Specifications and Qualifications: Education / Experience: Ø High School Diploma or GED required; Associate or Bachelor's in Life Sciences preferred. Ø Minimum 1-2 years' experience in sterile pharmaceutical manufacturing, 503B outsourcing, or hospital compounding strongly preferred. Ø Familiarity with cGMP, FDA 503B guidance, and aseptic technique required. Skills & Competencies: Ø Strong knowledge of sterile gowning and aseptic technique. Ø Ability to work in controlled cleanroom environments. Ø Excellent attention to detail, documentation accuracy, and adherence to SOPs. Ø Strong teamwork and communication skills. Licensing and Certifications: Ø Registered Pharmacy Technician Certification Ø Ability to maintain Gowning Certification _____________________________________________________________________________ Working Conditions / Physical Requirements: Ø Work performed primarily in classified cleanroom environments with strict gowning requirements. Ø Ability to lift up to 40 lbs and stand for extended periods. Ø Requires routine handling of sterile materials, chemicals, and equipment. Ø Shift work, weekends, and overtime may be required based on production demands.

Apply Description Job Title: Quality Operations Secondary Packaging Tier I Reports To: Quality Operations Secondary Packaging Supervisor FLSA Status: Non-Exempt _______________________________________________________________________________________________ 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, ophthalmics, 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. 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. Our quality first culture is built on: Transformation, Execution and Trust. ____ Job Purpose: Ø Performs Quality Attribute Inspections of the product through the packaging process in compliance with company policies/procedures, FDA and cGMP regulations. Ø Ensures the accuracy and completeness of batch records. Ø Performs other duties as assigned or apparent. ____ Essential Duties and Responsibilities: Ø Review Batch Records and applicable documentation to ensure complete, thorough and accurate data. Ø Responsible for ensuring a high level of employee accountability and performance. Ø Maintains quality assurance documentation including shift pass downs. Ø Keep QA work station clean and orderly. Ø Perform packaging line clearances. Ø Pull Retain, Stability, and Lab samples. Ø Perform or verify Quality Finished Product Attribute Inspections. Ø Perform AQL Calculations. Ø Verify component Exhibits Ø Verify all documents are present within the batch record. Ø Support validation and manufacturing studies, including special sampling and testing. Ø Communicate with Management any quality issues identified with product Supplemental Functions: Ø Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations. Ø Assist with development of solutions for chronic problems within quality assurance Ø Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management. Ø Adherence to cGMPs is required at all times. All personnel own the quality of the product delivered and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. Ø Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. Ø Assist in other activities (as needed) for Quality Assurance management. ____ Job Specifications and Qualifications: Skills: Detail oriented. Technical writing skills required. Good written, oral and comprehensive communication skills. Operating computer and relevant software;. Must be proficient in MS Word, Excel, and PowerPoint; Abilities: The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication; and provides participation, learning, feedback and recognition. The ability to effectively manage one's self, demonstrates integrity, be productive under pressure, and achieve development goals. Ability to handle contending priorities and managing partner expectations The ability and willingness to change direction and focus to meet shifting organizational and business demands. Assist in other activities (as needed) for Quality Operations management. Must have the ability to make recommendations to effectively resolve problems or issues by using judgment that is consistent with applicable standards, practices, policies, procedures, regulation or government law. Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. Education/Experience: Minimum of High School Diploma or GED required. ____ Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 25 1bs.), standing, sitting and walking throughout the facility. _____ 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.

The Audit Manager is responsible for the internal audit program, supplier quality management and coordination/execution of customer and regulatory audits. Responsibilities: Ensure execution of internal audits according to the Internal Audit Master Plan Track the execution of corrective action implementation of audit findings Provide oversight to supplier quality management process Conduct supplier audits including on-site inspections when required Maintain a history of audits performed and schedule repeat audits as required Coordinate and manage supplier quality alerts Coordinate and participate in regulatory and customer audits Perform trending of audit findings and identify opportunities for improvement Maintain current knowledge of regulations and guidance documents Manage and mentor audit personnel Qualifications: Four year college degree in Pharmacy, Chemistry, Biology or related field 5-10 years' experience in the pharmaceutical industry with a quality background Thorough knowledge of cGMP/ 21CFR with related experience in regulatory and compliance ASQ Certified Quality Auditor required Experience with FDA audits Proficient with current word processing and database software Strong interpersonal/group skills with ability to motivate and direct others Strong communication skills, verbal and written Qualifications Qualifications: Four year college degree in Pharmacy, Chemistry, Biology or related field 5-10 years' experience in the pharmaceutical industry with a quality background Thorough knowledge of cGMP/ 21CFR with related experience in regulatory and compliance ASQ Certified Quality Auditor required Experience with FDA audits Proficient with current word processing and database software Strong interpersonal/group skills with ability to motivate and direct others Strong communication skills, verbal and written

Apply 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 appropriate reporting systems and release forms. Mentor and train Chemists as needed to support laboratory operations. Assist in troubleshooting equipment, analyses, etc. Support and contribute to investigation documentation, as needed. Supplemental Functions: Relies on instructions and pre-established guidelines to perform job functions. Performs other similar duties as required. Works under supervision. Job Specifications and Qualifications: Knowledge & Skills: Strong analytical skills, problem-solving ability, and attention to detail. Sound understanding of cGMP regulations pertaining to laboratory controls and thorough knowledge of USP and compendia standards. Ability to read, understand, review, and update Standard Operating Procedures, Forms, and Specifications and assist in designing new procedures as necessary independently, subject to management guidance. Ability to perform testing and lead root cause analysis for laboratory investigations for OOS and atypical QC test results, subject to management guidance. Ability to effectively communicate within Chemistry Laboratory Staff and Management, as well as other departments. Acknowledge and identify continuous improvement opportunities in all work activities. Initiate and follow through to implement, track, and achieve on-time completion of testing to support sample release to meet business needs and demands. Ability to effectively use a multitude of resources to perform job functions accurately. Education/Experience: BS or MS in Chemistry, Biochemistry, or related field required with 2-5 years of pharmaceutical experience preferred. Experience outside of pharmaceuticals in chemistry quality control or R&D will be considered for the highly qualified candidate. Experience with conducting analysis by FT-IR, UV/Vis spectroscopy, and wet chemistry techniques is required. Highly skilled in advanced techniques such as HPLC, GC, and ICP testing, needing little or no guidance and supervision. Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 40 lbs.), standing, sitting and walking throughout the facility. This position encounters the following environmental factors: hazardous materials including HPLC solvents, chemical reagents, acids, and other non-specified hazardous materials that are project specific. This position requires safety glasses and other non-specified personal protective equipment to be worn as necessary.

Apply 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, and has distributed over 1 billion doses of respiratory medication per year since 2009. 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: The BFS Maintenance Technician 1 is an entry-level role focused on assisting with the operation and basic maintenance of Blow-Fill-Seal (BFS) equipment. This role supports senior technicians and line mechanics by performing routine preventive maintenance, documenting work activities, and helping resolve minor mechanical and electrical issues. The Technician 1 ensures operations meet CGMP and safety standards while gaining hands-on experience in sterile pharmaceutical manufacturing. _________________________________________________________________________________________ Essential Duties and Responsibilities: Equipment Support & Basic Maintenance: Ø Assist in the operation and routine maintenance of BFS production equipment. Ø Perform basic troubleshooting under supervision (e.g., minor jams, adjustments). Ø Support changeovers and machine setups. Ø Help identify and report unusual machine behavior or defects. Compliance & Documentation: Ø Follow all CGMP and FDA guidelines in cleanroom and production areas. Ø Complete maintenance logs and standard forms accurately and on time. Ø Support SOP adherence and equipment checklists during each shift. Training & Development: Ø Participate in on-the-job training under guidance from BFS Maintenance Technician 2 or Supervisor. Ø Learn technical fundamentals of BFS equipment, cleanroom and compliance procedures. Ø Attend assigned training and demonstrate growing mechanical competence. Safety & Cleanroom Expectations: Ø Follow all safety rules and lockout/tagout procedures. Ø Wear appropriate PPE and comply with gowning requirements including proper aseptic technique. Ø Sanitize tool, equipment and area as necessary by procedures. Job Specifications and Qualifications: Knowledge: Ø Basic understanding of mechanical or electrical systems. Ø Willingness to learn BFS equipment and maintenance practices. Ø Familiarity with tools, safety procedures, and production environments. Education / Experience: Ø High school diploma or GED required. Ø 1-2 years of experience in a manufacturing, maintenance, or technical support role preferred. Ø Prior BFS experience preferred; training provided. Licensing and Certifications: Ø Technical certification in maintenance, electrical, or mechanical systems preferred but not required. _____________________________________________________________________________ Working Conditions / Physical Requirements: Ø Ability to lift up to 50 - 70 lbs, bend, reach, and stand for extended periods. Ø Must be able to work in a cleanroom setting with appropriate PPE. Ø 12-hour rotating shifts (2-2-3 schedule); shift assignment may vary. Ø Salary range: Based on experience. Ø May be asked to participate in on-call rotation.

Apply Description Essential Duties and Responsibilities: Coordinates daily activities to monitor environment, air quality, and personnel samples in production area and complete daily review of aseptic monitoring data entry and/or form completion. Ability to monitoring in all ISO classified production areas. Coordinates sampling program for facility water for injection (WFI) system. Assists with training of newly hired EM Technicians; also ensures the continuous training of all of EM Techs in all cleanroom production areas, and with all new equipment and machines (including, but not limited to, Continuous Particle Measuring System). Executes data entry and/or form completion and verification. Performs additional laboratory tasks and assists in EM-related projects as needed. Ensures EM Technicians are utilizing MODA per procedure, and assist Microbiology Management in providing trend data and reports for analysis. Develops and distribute daily EM schedule and ensure it is followed. Covers monitoring activities, as necessary, to ensure support in all areas are covered each shift. Maintains inventory necessary for EM program operation. Communicate quality-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to the EM Supervisor, EM Assistant Manager(s), EM Program Manager and/or Director of Microbiology or designee. Supplemental Functions: Performs other duties as assigned. Job Specifications and Qualifications: Knowledge & Skills: Team player - must be able to interact with multiple company departments. Flexible and open to receive and provide training in other areas and accept new changes in order to achieve department demands. Must have strong organizational skills and be able to manage multiple projects or assignments at one time. The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business. Experience in operation of non-viable particulate counter, Continuous Particle Measuring System, Hygrometer, Viable air sampler, and successful aseptic gowning. Specific expertise, skills, and knowledge within Microbiology gained through education and experience. The ability to manage a multitude of resources; and to be accurate and current with data and information. A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities. The ability to take strategic objectives and accept accountability, and to motivate and influence others to drive results through effective actions. The ability and willingness to change direction and focus to meet shifting organizational and business demands. The ability to effectively manage one's self, demonstrate integrity, be productive under pressure, and achieve development goals. Incumbents required to wear specified protective equipment, as necessary. Education/Experience: Associates of Science degree minimum, Bachelor's degree preferred. 1 - 2 years of experience in pharmaceutical industry or clinical background with cGMP knowledge preferred. Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 40 1bs.), reaching, vision, talking, hearing, standing, sitting, and walking throughout the facility. Hours of Work: 12-hour rotating shift. Salary range: Based on experience.

The Project Manager provides overall management of projects within TRC. The project manager will focus on company projects as they impact all departments, as well as future TRC business. The role will ensure projects are defined and managed in a clear and concise manner so that all participants, including managers, team members, and vendors, understand the project expectations, resources, and timelines. Responsibilities: Ensures a uniform definition of all company projects including objective, scope, approach, members, responsibilities, and timelines. Establish and maintain project schedules and report any variances as soon as recognized. Establish and maintain internal/external meeting agendas and minutes. Understands and assists teams identify critical path to ensure efficient and timely project success. Ensures and promotes multi-departmental communication required for cross functional projects. Identifies and assesses project impact to all departments as well as future company goals. Reports project information that may impact timelines, cash flow, product quality, resources, and other relevant information. Support organizational Project Management Office (PMO) processes/projects as needed. Qualifications: Bachelors in Physical Sciences, Engineering, Health Care, Life Sciences or Project Management or Associates Degree with ten (10) years of continuous working experience in Pharmaceuticals. 3-5 years project management experience in Pharmaceutical CDMO/CMO industry with PMP Certification preferred. Knowledge of project management tools and techniques including Six Sigma desired. Knowledge of cGMP and CFR Guidelines. Strong interpersonal/group written and verbal communication skills.

Apply Description The Manager of Financial Planning and Analysis (FP&A) will lead our financial modeling, forecasting, and analysis functions. They will have a deep understanding of financial strategy, exceptional attention to detail, and proven experience in credit modeling, restructuring, or FP&A within a professional services or consulting firm environment. This role requires a blend of strategic thinking, hands-on financial analysis, and teamwork. Essential Duties and Responsibilities: Ø Strategic Financial Leadership: o Develop and implement financial strategies that align with long-term business objectives. o Analyze operational challenges and recommend solutions to optimize financial performance. Ø Operational Efficiency: o Identify inefficiencies in operational processes and recommend cost-saving measures. o Develop actionable insights to improve overall financial health and organizational efficiency. Ø Teamwork: o Foster a collaborative, team-oriented culture that encourages innovation and high performance. Supplemental Functions: Ø Performs other similar duties as required. ____ Job Specifications and Qualifications: Ø Financial Analysis and Modeling: o Build, maintain, and enhance complex financial models, including: § 13-week cash flow forecasting. § Company annual and long-range financial model. § Covenant compliance analysis. § Profitability and liquidity assessment. o Perform sensitivity analyses to evaluate the impact of various financial scenarios. o Analyze financial statements to identify trends, risks, and opportunities for improvement. o Collaborate with stakeholders to understand and refine model assumptions. o Maintain expertise in asset-based lending environments and borrowing base certificates. Education/Experience: Bachelor's degree in Finance or a related field, with five (5+) years of experience of progressive finance experience. (Master's degree preferred) Licensing and Certifications: Certified Public Accountant (CPA) optional Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 20 1bs.), standing, sitting and walking throughout the facility.

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 appropriate reporting systems and release forms. * Mentor and train Chemists as needed to support laboratory operations. * Assist in troubleshooting equipment, analyses, etc. * Support and contribute to investigation documentation, as needed. Supplemental Functions: * Relies on instructions and pre-established guidelines to perform job functions. * Performs other similar duties as required. * Works under supervision. Job Specifications and Qualifications: Knowledge & Skills: * Strong analytical skills, problem-solving ability, and attention to detail. * Sound understanding of cGMP regulations pertaining to laboratory controls and thorough knowledge of USP and compendia standards. * Ability to read, understand, review, and update Standard Operating Procedures, Forms, and Specifications and assist in designing new procedures as necessary independently, subject to management guidance. * Ability to perform testing and lead root cause analysis for laboratory investigations for OOS and atypical QC test results, subject to management guidance. * Ability to effectively communicate within Chemistry Laboratory Staff and Management, as well as other departments. * Acknowledge and identify continuous improvement opportunities in all work activities. Initiate and follow through to implement, track, and achieve on-time completion of testing to support sample release to meet business needs and demands. * Ability to effectively use a multitude of resources to perform job functions accurately. Education/Experience: * BS or MS in Chemistry, Biochemistry, or related field required with 2-5 years of pharmaceutical experience preferred. Experience outside of pharmaceuticals in chemistry quality control or R&D will be considered for the highly qualified candidate. * Experience with conducting analysis by FT-IR, UV/Vis spectroscopy, and wet chemistry techniques is required. * Highly skilled in advanced techniques such as HPLC, GC, and ICP testing, needing little or no guidance and supervision. Working Conditions / Physical Requirements: * This position requires bending, typing, lifting (up to 40 lbs.), standing, sitting and walking throughout the facility. * This position encounters the following environmental factors: hazardous materials including HPLC solvents, chemical reagents, acids, and other non-specified hazardous materials that are project specific. * This position requires safety glasses and other non-specified personal protective equipment to be worn as necessary.