What are the responsibilities and job description for the BFS Supervisor Shift 3 (Nights) position at Nephron Pharmaceuticals?
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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, 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.
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Job Purpose
The BFS Supervisor is responsible for overseeing the operation, maintenance, and performance of Blow-Fill-Seal (BFS) production lines. This role ensures that manufacturing activities comply with Current Good Manufacturing Practices (CGMP), safety regulations, and company policies. The Supervisor leads a team of operators and technicians to meet production goals, maintain high-quality standards, and drive continuous improvement in efficiency and process reliability.
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Essential Duties And Responsibilities
Leadership & Team Management:
Ø Supervise BFS Operators, Line Leads, and Technicians to ensure smooth daily operations.
Ø Provide coaching, training, and mentorship to enhance team performance and technical skills.
Ø Monitor and enforce adherence to CGMP, safety, and company policies.
Ø Conduct performance evaluations and provide feedback for professional growth.
Production Oversight
Ø Plan and coordinate daily production schedules, ensuring optimal machine utilization.
Ø Ensure proper execution of batch records, SOPs, and process documentation.
Ø Collaborate with cross-functional teams (Quality, Maintenance, Engineering) to address production challenges and optimize workflows.
Ø Ensure adherence to aseptic techniques and sterility assurance measures.
Equipment & Process Management
Ø Oversee BFS equipment operation, maintenance schedules, and troubleshooting efforts.
Ø Work with Maintenance teams to plan preventive maintenance and minimize downtime.
Ø Analyze equipment performance data and implement improvements.
Quality & Compliance
Ø Ensure all production activities comply with CGMP, FDA, and company quality standards.
Ø Participate in deviation investigations, root cause analysis, and corrective/preventive action implementation.
Ø Support internal and external audits, providing necessary documentation and responses.
Continuous Improvement
Ø Identify and implement process improvements to enhance efficiency and reduce waste.
Ø Participate in lean manufacturing and Six Sigma initiatives.
Ø Monitor key performance indicators (KPIs) and take proactive steps to meet production targets.
Safety & Housekeeping
Ø Enforce safety protocols, conduct risk assessments, and ensure a safe work environment.
Ø Promote a culture of cleanliness, organization, and compliance with 5S principles.
Supplemental Functions
Ø Performs all other duties as assigned or apparent.
Knowledge
Job Specifications and Qualifications:
Ø Strong leadership and supervisory experience in a regulated production environment.
Ø Expertise in BFS technology, troubleshooting, and aseptic processing.
Ø Strong knowledge of CGMP, FDA regulations, and compliance standards.
Ø Excellent problem-solving, organizational, and communication skills.
Education/Experience
Ø High school diploma or equivalent required; Bachelor's degree in Engineering, Manufacturing, or related field preferred.
Ø 5 years of experience in BFS or sterile pharmaceutical manufacturing.
Licensing And Certification
Ø Certification in Lean Manufacturing, Six Sigma, or similar process improvement methodologies.
______________________________________________________________________________
Working Conditions / Physical Requirements
Ø Ability to lift and carry heavy equipment (up to 50 lbs), stand for extended periods and work in a cleanroom environment.
Ø Comfortable wearing personal protective equipment (PPE), such as gloves, gowns, masks and goggles.
Ø Salary range: Based on experience.
Ø Hours of Work: 12-hr shift work (0600-1830, 1800-0630).
______________________________________________________________________________
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.
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, 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
The BFS Supervisor is responsible for overseeing the operation, maintenance, and performance of Blow-Fill-Seal (BFS) production lines. This role ensures that manufacturing activities comply with Current Good Manufacturing Practices (CGMP), safety regulations, and company policies. The Supervisor leads a team of operators and technicians to meet production goals, maintain high-quality standards, and drive continuous improvement in efficiency and process reliability.
______________________________________________________________________________
Essential Duties And Responsibilities
Leadership & Team Management:
Ø Supervise BFS Operators, Line Leads, and Technicians to ensure smooth daily operations.
Ø Provide coaching, training, and mentorship to enhance team performance and technical skills.
Ø Monitor and enforce adherence to CGMP, safety, and company policies.
Ø Conduct performance evaluations and provide feedback for professional growth.
Production Oversight
Ø Plan and coordinate daily production schedules, ensuring optimal machine utilization.
Ø Ensure proper execution of batch records, SOPs, and process documentation.
Ø Collaborate with cross-functional teams (Quality, Maintenance, Engineering) to address production challenges and optimize workflows.
Ø Ensure adherence to aseptic techniques and sterility assurance measures.
Equipment & Process Management
Ø Oversee BFS equipment operation, maintenance schedules, and troubleshooting efforts.
Ø Work with Maintenance teams to plan preventive maintenance and minimize downtime.
Ø Analyze equipment performance data and implement improvements.
Quality & Compliance
Ø Ensure all production activities comply with CGMP, FDA, and company quality standards.
Ø Participate in deviation investigations, root cause analysis, and corrective/preventive action implementation.
Ø Support internal and external audits, providing necessary documentation and responses.
Continuous Improvement
Ø Identify and implement process improvements to enhance efficiency and reduce waste.
Ø Participate in lean manufacturing and Six Sigma initiatives.
Ø Monitor key performance indicators (KPIs) and take proactive steps to meet production targets.
Safety & Housekeeping
Ø Enforce safety protocols, conduct risk assessments, and ensure a safe work environment.
Ø Promote a culture of cleanliness, organization, and compliance with 5S principles.
Supplemental Functions
Ø Performs all other duties as assigned or apparent.
Knowledge
Job Specifications and Qualifications:
Ø Strong leadership and supervisory experience in a regulated production environment.
Ø Expertise in BFS technology, troubleshooting, and aseptic processing.
Ø Strong knowledge of CGMP, FDA regulations, and compliance standards.
Ø Excellent problem-solving, organizational, and communication skills.
Education/Experience
Ø High school diploma or equivalent required; Bachelor's degree in Engineering, Manufacturing, or related field preferred.
Ø 5 years of experience in BFS or sterile pharmaceutical manufacturing.
Licensing And Certification
Ø Certification in Lean Manufacturing, Six Sigma, or similar process improvement methodologies.
______________________________________________________________________________
Working Conditions / Physical Requirements
Ø Ability to lift and carry heavy equipment (up to 50 lbs), stand for extended periods and work in a cleanroom environment.
Ø Comfortable wearing personal protective equipment (PPE), such as gloves, gowns, masks and goggles.
Ø Salary range: Based on experience.
Ø Hours of Work: 12-hr shift work (0600-1830, 1800-0630).
______________________________________________________________________________
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.
