3rd Shift Pharmaceutical Technician - Group Leader

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.

Position: 3rd Shift Pharmaceutical Technician – Group Leader

Department: Operations

Location: Somerset (US)

Ardena is hiring a Group Leader for the Operations team at our Somerset site. This role supports pharmaceutical development and manufacturing activities within a GMP‑regulated environment.

• Actively lead manufacturing operations by working hands‑on with manufacturing technicians, rolling up their sleeves to support the team, and ensuring productive, safe, and compliant operations on the production floor.
• Monitor projects to ensure agreed upon customer and department timelines are met and report progress of projects to manufacturing leadership.
• Demonstrate technical proficiency and ability to independently troubleshoot complex manufacturing and equipment related problems.
• Foster a culture of Continuous Improvement and assist on projects that increase safety, productivity, and compliance.
• Lead and perform unit operations (work centers) consisting of and not limited to Hot Melt Extrusion, Fluid Bed, Roller Compaction, Encapsulation, Compression, Coating, Milling, Blending, Sifting, Dispensing, and other processes where assigned.
• Ensure document accuracy via completion of batch records, phase reviews, logbooks, label verification, and raw material verification.
• Check for accuracy all materials delivered from the dispensing area as well as all in‑process materials from the prior unit operation as per current SOP.
• Support authoring of deviations, SOPs, risk assessments, and other records as they relate to operations.
• Release rooms and equipment following cleaning validation sampling, facilities maintenance, or other activities.
• Perform and grant line clearance.
• Ensure consumable materials are fully stocked and request more as needed.
• Assign equipment and room cleaning when required.
• Serve as a subject matter expert and role model in the assigned area by demonstrating proper procedures, sound judgment, hands‑on support, and adherence to safety, cGMP, SOP, and documentation requirements.
• Reports to manufacturing supervisor. Comprehends and adheres to all pertinent Health and Safety Regulations, Policies and Procedures and all cGMP’s and other Regulatory requirements and all related SOP’s as well as Batch Records and Protocols.
• Perform room and equipment inspections and complete all pertinent documentation.
• Train, coach, mentor, and provide day‑to‑day support and guidance to peers and team members in the assigned area of expertise.
• Other duties as assigned.

• Degree in a relevant scientific or technical field (e.g., Chemistry, Pharmacy, Biochemistry, Engineering) or equivalent professional experience.
• Relevant industry experience in pharmaceutical development, manufacturing, or life sciences.
• Demonstrated ability to work effectively in GMP‑regulated environments.
• Fluent in English, both written and spoken (required across all Ardena sites).
• Strong communication, collaboration, and problem‑solving skills.
• [Add role‑specific qualifications here].

• Education or Equivalent Requirements:
• High School diploma or equivalent (GED).

• 3+ years working in a pharmaceutical, biotech, or food manufacturing environment (regulated by GMP standards and requirements); subject matter expert in manufacturing operations with hands‑on experience in at least three of the work center…