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.

Job Overview

Position: 3rd Shift Pharmaceutical Technician - Group Leader

Department: Operations

Location: Somerset (US)

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

Key Responsibilities

· 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 reports 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

Required Qualifications:

• 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]

Preferred Qualifications:

• Education or Equivalent Requirements:

· High School diploma or equivalent (GED).

Experience:

· 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 disciplines.

Knowledge/Skills Requirements:

• Ability to utilize hand tools to assemble and disassemble various types of machinery.

• Ability to follow instructions and procedures (SOPs, cGMPs).

• Work in a safe manner.

• Computer literacy, solid communication (in English), and legible handwriting skills are necessary.

• Proficient reading and comprehension skills.

• Strong leadership skills and decision-making skills.

• Mechanically inclined candidates are preferred.

• Technical skills/trouble shooting skills. Demonstrate a high level of technical expertise and

problem solving skills.

• Exemplary leadership skills with the ability to role model expected behaviors, coach and train peers and team-members, and provide support and guidance in a team-based manufacturing environment.

• Grammatical and communication skills, both written and oral to keep others informed of progress and changes in status of work

• Able to work as part of team and adapt to changes in work duties

• Detail-oriented, thorough, methodical, and able to effectively meet deadlines.

• Mathematical and reasoning ability.

• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Physical Requirements:

· Individual may be required to sit, stand, walk regularly

· Individual may be required to bend, kneel, crouch, and stoop

· Occasionally lift 0-50 pounds

· Individual may be required to wear a respirator for several hours at a time due to work associated

with potent compounds.

· Be accessible to manufacturing floor and office staff and to use required office equipment

· Specific vision requirements include reading of written documents and frequent use of computer monitor

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

How to Apply

Ready to advance your career in pharmaceutical development? Apply now through the Ardena Careers website at careers.ardena.com.

Salary Range: $78,000 - $85,000