3rd Shift Supervisor

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.

About the role

As a 3rd Shift Supervisor at Ardena, you will contribute to pharmaceutical development projects by performing scientific, technical, or operational activities within 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

• 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.

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.
• 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.

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.

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.

Pay

$90,000 - $100,000 BOE

Schedule

3rd Shift: 11:00 PM - 7:30 AM