Scientist – Quality Control (QC)

Ardena • Somerset, NJ

8d • Onsite

About The Position

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. 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 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. The successful candidate will perform laboratory testing using a variety of analytical techniques while ensuring compliance with cGMP, data integrity, and regulatory requirements. This position offers the opportunity to contribute directly to the quality, safety, and timely release of pharmaceutical products supporting patients worldwide.

Requirements

• 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, and Electronic Laboratory Notebooks (ELN).
• Strong organizational, analytical, and problem-solving skills.
• Excellent verbal and written communication skills.
• Ability to effectively manage multiple priorities while meeting project deadlines.
• Fluent in English, both written and spoken

Nice To Haves

• Experience supporting pharmaceutical development and commercial manufacturing environments.
• Working knowledge of cGMP, FDA regulations, and data integrity requirements.
• Experience authoring or reviewing SOPs, analytical methods, laboratory investigations, deviations, and technical reports.
• Proficiency with Microsoft Office applications, including Teams, Word, Excel, and PowerPoint.
• Experience working collaboratively with cross-functional technical teams.
• Alignment with Ardena's CARE values: Communicative Accountable Reliable Excellent

Responsibilities

• 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.
• 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.

Benefits

• Competitive salary and comprehensive benefits package.
• Paid time off and company-recognized holidays.
• Medical, dental, vision, life, and disability insurance.
• 401(k) retirement savings plan with company match.
• Professional development and training opportunities.
• Collaborative international work environment across Europe and the United States.
• Opportunities to contribute to innovative pharmaceutical development projects that improve patient health.
• A values-driven culture guided by Ardena's CARE principles: Communicative, Accountable, Reliable, and Excellent.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree