Scientist – Quality Control; QC

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's European sites are located in Oss and Assen (the Netherlands), Ghent (Belgium), and Pamplona (Spain). Ardena's U.S. facility is based in Somerset, New Jersey.

For our Somerset, New Jersey site, we are looking for a Scientist – Quality Control (QC) to join our Quality Assurance Division.

Position:
Scientist – Quality Control (QC)

Division:
Quality Assurance

Department:
Quality Control

Location:

Somerset, New Jersey

FLSA Status:
Exempt

Employment Type:

Full-Time

Ardena is seeking a Scientist – Quality Control (QC) to join our Quality Control team in Somerset, NJ. This role supports pharmaceutical development and commercial manufacturing by performing analytical testing of raw materials, in-process materials, finished products, and stability samples within a GMP-regulated laboratory environment.

As a Scientist – Quality Control (QC) at Ardena, you will independently perform analytical testing and support quality control activities for clinical and commercial pharmaceutical products. You will analyze laboratory data, interpret results, investigate deviations, and communicate findings through technical reports and documentation.

Working in a GMP-regulated laboratory, you will collaborate closely with cross-functional teams including Quality Assurance, Manufacturing, Regulatory Affairs, Project Management, and other technical departments to ensure projects are completed on schedule while maintaining the highest standards of quality and compliance.

• Perform analytical testing of raw materials, in-process materials, finished products, and stability samples to support pharmaceutical development and commercial manufacturing.
• Independently execute laboratory testing with accuracy while maintaining complete and compliant documentation.
• Analyze laboratory data, evaluate results for accuracy and integrity, and communicate findings through technical reports and presentations.
• Perform Quality Control activities required to meet project timelines and customer deliverables.
• Utilize analytical techniques including, but not limited to:
  • High Performance Liquid Chromatography (HPLC/LC)
  • Gas Chromatography (GC)
  • Dissolution Testing
  • Standard Wet Chemistry
• Operate laboratory instrumentation and electronic systems including CDMS, LIMS, ELN, and other laboratory software.
• Review analytical data for completeness, accuracy, and compliance with regulatory and data integrity requirements.
• Conduct and document laboratory investigations, deviations, and change management activities.
• Author and review analytical methods, protocols, reports, specifications, and Standard Operating Procedures (SOPs).
• Collaborate with cross-functional teams to ensure project objectives and customer timelines are achieved.
• Support Quality Systems and laboratory infrastructure initiatives.
• Maintain compliance with cGMP, Health, Safety, Environmental, and Data Integrity requirements.
• Perform additional technical and administrative duties as assigned.

• Associate's degree in Chemistry or Analytical Chemistry with 5+ years of experience supporting pharmaceutical product development and manufacturing.
• OR
• Bachelor's degree in Chemistry or Analytical Chemistry with 3+ years of experience supporting pharmaceutical product development and manufacturing.
• Experience working within a GMP-regulated pharmaceutical laboratory.
• Strong understanding of analytical chemistry principles and pharmaceutical Quality Control practices.
• Experience performing analytical testing using chromatographic and wet chemistry techniques.
• Proficiency with analytical instrumentation, including LC (HPLC), GC, and Dissolution systems.
• Experience using laboratory electronic systems such as CDMS, LIMS,…