3rd Shift Supervisor

Ardena; Northern (KY); Hybrid; USD 90,000 - 100,000; Full time

Benefits offered by this job

Competitive salary

Flexible working arrangements

International collaboration

Professional development and training

Job summary

Ardena, a global CDMO/CRO, seeks a 3rd Shift Supervisor for the Somerset, NJ site. You will lead production personnel in a GMP-regulated environment, ensuring safe, compliant, and efficient manufacturing and packaging operations across the night shift.

The role requires coordinating staffing, training, batch records, and equipment troubleshooting while collaborating with Quality, Regulatory, and Project Management teams to support commercial and clinical programs.

Qualifications

• 1+ years of experience in pharmaceutical, food, or other GMP-regulated manufacturing environments.
• Previous project leadership or team leadership experience required.
• Supervisory experience 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.

Skills

Team leadership

GMP knowledge

Communication

Education

Bachelor's degree in Engineering/Science

Associate degree or equivalent experience

Job description

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.

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.

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.
• 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.

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.

What Ardena Offers

Ardena is a science-driven and people-focused employer. Working at Ardena means contributing to pharmaceutical projects that support the availability, safety, and quality of medicines for patients worldwide.

Ardena offers an international working environment where employees are encouraged to develop their expertise, take ownership, and grow their careers across functions and locations.

Benefits and perks at Ardena include

• 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

Salary Range: $90,000 - $100,000 BOE