3rd Shift Supervisor

About Ardena

Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market.

Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market.

The Ardena Group operates from five sites across Europe and the United States, employing more than 750 professionals. Ardena European sites are located in Oss and Assen (the Netherlands), Ghent (Belgium), and Pamplona (Spain). Ardena US facility is based in Somerset, New Jersey.

Ardena provides integrated services spanning drug substance development, drug product formulation, GMP manufacturing, bioanalytical services, clinical logistics, fill and finish, and CMC regulatory support.

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.

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.

• 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.

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.

• 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, Master Control) preferred.
• Proficient in Microsoft Office applications.
• Strong…