Blow Fill Seal (BFS) Supervisor - Nights at Nephron Pharmaceuticals in West Columbia, South Carolina

Job Description:

Corporate Statement

Nephron Pharmaceuticals Corporation 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. Nephron is currently working on research and development projects that include over 50 new products. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe. Nephron exists to provide top-quality, affordable medications to everyone.

Position Summary:

The Blow Fill Seal (BFS) Supervisor is responsible for overseeing the day-to-day operations of the BFS production lines, ensuring that production targets are met while maintaining compliance with safety, quality, and regulatory standards. The BFS Supervisor leads and manages a team of operators and technicians, ensuring the smooth execution of production processes, troubleshooting issues, and fostering a culture of continuous improvement.

Primary Accountabilities:

• Production Oversight:
  • Supervise BFS production operations to ensure efficient and effective manufacturing of sterile products.
  • Coordinate daily activities, including production schedules, workforce assignments, and resource allocation.
  • Monitor production lines to ensure proper operation of BFS equipment and adherence to production goals.
• Team Leadership:
  • Direct and oversee the activities of BFS operators and technicians, providing leadership, coaching, and technical support.
  • Ensure proper training for all team members and monitor ongoing performance.
  • Conduct regular team meetings to review production metrics, address challenges, and communicate updates.
• Quality Control and Compliance:
  • Ensure compliance with cGMP, FDA, and other relevant regulatory standards for sterile manufacturing.
  • Work closely with the Quality Assurance team to identify, report, and resolve deviations or non-conformances.
  • Maintain accurate production documentation, including batch records, logs, and reports.
• Troubleshooting and Process Improvement:
  • Identify and resolve issues that arise during production, including equipment malfunctions and quality deviations.
  • Collaborate with the maintenance team to ensure timely repairs and routine maintenance of BFS equipment.
  • Participate in continuous improvement initiatives to enhance production efficiency, reduce waste, and optimize processes.
• Safety and Compliance:
  • Promote and enforce safety standards, ensuring that all team members adhere to safety protocols, including the use of PPE.
  • Conduct regular safety inspections and report any incidents or potential hazards.
  • Ensure a clean and sterile environment within the BFS production area.

NOTE: The primary accountabilities and the knowledge, skills and abilities listed below, are intended to describe the general content of and requirements for this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents' performance objectives as outlined by the incumbents' immediate supervisor or manager.

Knowledge, Skills & Abilities:

• Associate's degree in Engineering, Biotechnology, or a related technical field, or equivalent experience.
• Minimum of 3-5 years of experience in a BFS or sterile manufacturing environment.
• Hands-on experience with BFS equipment, including setup, operation, and troubleshooting.
• Strong leadership and supervisory abilities with experience managing production teams.
• Solid understanding of cGMP, FDA regulations, and sterile production processes.
• Strong problem-solving and decision-making skills.
• Experience in sterile pharmaceutical or healthcare manufacturing.
• Knowledge of Lean Manufacturing principles or Six Sigma methodologies.
• Previous experience in a supervisory role.
• The position operates in a sterile manufacturing facility with gowning and hygiene compliance requirements.
• Shift work, including nights and weekends, may be required based on production needs.
• Position requires reaching (waist to overhead), bending (waist to floor), climbing (floor to ceiling), lifting (up to 20 lbs), vision (20/20), good hearing, standing (30% of shift time), crawling, sitting, gripping, talking and walking (30% of shift time). Exposed to the environment factor of heat.
• Incumbents are required to comply with proper gowning requirements, wear safety glasses, hearing protection, and other non-specified protective equipment as necessary.
• Salary range: Based on experience

EEO Statement:

Nephron 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, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.

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