3rd Shift Supervisor

Ardena • Somerset, NJ

1d • Onsite

About The Position

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. 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.

Requirements

• 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.
• 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.
• 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.
• Proficient in Microsoft Office applications.
• Strong organizational, troubleshooting, and problem-solving capabilities.
• Demonstrated ability to drive productivity improvements and reduce operational downtime.

Nice To Haves

• Supervisory experience preferred.
• Experience with ERP and QMS platforms (e.g., Business Central, MasterControl) preferred.

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.
• Coordinate staffing, employee training, cross-training, performance management, scheduling, time-card and time-off approvals.
• 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.

Benefits

• Competitive salary and tailored benefits package (adjusted per role and location)
• Flexible working arrangements and paid annual leave (where applicable, depending on role and site)
• International and collaborative work environment across European and US sites
• Access to professional development and training programs
• Meaningful work on pharmaceutical development projects that advance patient health
• A values-driven culture guided by Ardena’s CARE principles: Communicative, Accountable, Reliable, and Excellent

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level