Bachelor's Degree in Engineering, Chemistry, Mathematics, Physics, or related field with 1+ years in a GMP-regulated environment.
Associate Degree or equivalent experience with 4+ years in GMP-regulated settings and 2+ years in leadership roles.
Knowledge of FDA cGMP requirements and DEA regulations.
Hands-on experience with pharmaceutical manufacturing and packaging processes.
Strong leadership and team development skills.
Responsibilities
Supervise manufacturing and packaging operations ensuring compliance with applicable regulations.
Lead and develop production staff to enhance safety and productivity.
Coordinate staffing, training, and performance management activities.
Troubleshoot equipment issues and assist in operational problem solving.
Oversee the accuracy of batch records and production documentation.
Collaborate with cross-functional teams to support clinical and commercial programs.
Drive continuous improvement initiatives to enhance operational efficiency.
Benefits
Opportunity to contribute to impactful pharmaceutical development projects.
Work in a regulated environment with a focus on safety and compliance.
Access to professional growth through leadership development.
Engage in cross-functional collaboration with various departments.
Full Job Description
Ardena is hiring a 3rd Shift Supervisor; hours 11:00pm- 7:30am, to join the Manufacturing/Operations team at our Somerset, NJ site. This role supports pharmaceutical development and manufacturing activities within a GMP-regulated environment.
Role Description
As a 3rd Shift Supervisor at Ardena, you will contribute to pharmaceutical development projects by performing scientific, technical, or operational activities within the Operations. You will work in a regulated pharmaceutical environment, ensuring that all work meets GMP, GxP, and applicable ISO standards.
You will collaborate with cross-functional teams including Quality Assurance, Regulatory Affairs, Project Management, Production, and other departments across Ardena's European and US sites.
Summary
The Shift Supervisor is responsible for leading, training, and overseeing production personnel in a 24/5 pharmaceutical manufacturing environment. This role ensures safe, compliant, and efficient commercial and clinical manufacturing and packaging operations, including controlled substances (Schedules II-V). Responsibilities include staffing, quality oversight, production performance, material accountability, batch documentation, and continuous improvement initiatives to improve productivity and operational excellence.
Key Responsibilities
Supervise daily manufacturing and packaging operations in compliance with cGMP, FDA, DEA, OSHA, and company requirements.
Lead, coach, and develop production staff to ensure safe, compliant, and productive operations across shifts.
Troubleshoot manufacturing and packaging equipment issues and support operational problem solving.
Ensure accurate completion and review of batch records, equipment logs, material reconciliation, label verification, and production documentation.
Verify production order consumption and batch closure activities within ERP systems.
Investigate production deviations, out-of-specification events, and customer complaints using the QMS.
Support continuous improvement initiatives through process enhancements, corrective actions, and quality system improvements.
Maintain compliance with PPE requirements, safety procedures, and workplace regulations.
Collaborate with Quality, R&D, Project Management, Warehouse, and other cross-functional teams to support clinical and commercial programs.
Oversee manufacturing operations including blending, milling, sifting, encapsulation, compression, coating, fluid bed processing, hot melt extrusion, and related unit operations.
Perform inventory transactions, staging activities, reconciliation, and label generation within ERP systems.
Perform other duties as assigned.
Required Qualifications:
Bachelor's Degree in Engineering, Chemistry, Mathematics, Physics, or related scientific discipline with:
1+ years of experience in pharmaceutical, food, or other GMP-regulated manufacturing environments.
Previous project leadership or team leadership experience required.
Supervisory experience preferred.
OR
Associate Degree or equivalent experience with:
4+ years of experience in pharmaceutical, food, or other GMP-regulated manufacturing environments.
2+ years of leadership experience within a regulated manufacturing environment.
Knowledge & Skills
Working knowledge of FDA cGMP requirements and DEA regulations.
Strong leadership, communication, coaching, and team development skills.
Experience with pharmaceutical manufacturing and packaging processes and equipment.
Ability to review and complete GMP documentation accurately, including batch records and logbooks.
Knowledge of quality systems, deviation investigations, document control, and compliance requirements.
Experience with ERP and QMS platforms (e.g., Business Central, MasterControl) preferred.
Proficient in Microsoft Office applications.
Strong organizational, troubleshooting, and problem-solving capabilities.
Demonstrated ability to drive productivity improvements and reduce operational downtime.
Physical & Work Environment
This position is primarily based on the production floor with routine office work. The role requires standing, walking, and occasional lifting of up to 50 pounds. The environment is fast-paced and deadline-driven, requiring strong attention to detail, communication, and the ability to manage multiple priorities while maintaining compliance and operational excellence.
Salary Range: $90,000 - $100,000 BOE
How to Apply
Ready to advance your career in pharmaceutical development? Apply now through the Ardena Careers website at careers.ardena.com.
Department General Operations Locations Somerset (New Jersey, US)
