What are the responsibilities and job description for the Scientist – Quality Control (QC) position at Ardena?
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.
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: 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.
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.
Role Description
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.
Key Responsibilities
Required Qualifications
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
Ready to advance your career in pharmaceutical Quality Control?
Apply today through the Ardena Careers website at careers.ardena.com and become part of a team dedicated to advancing pharmaceutical innovation and improving patient lives worldwide.
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.
Job Overview
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.
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.
Role Description
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.
Key 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.
- 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.
Required Qualifications
- Associate's degree in Chemistry or Analytical Chemistry with 5 years of experience supporting pharmaceutical product development and manufacturing,
- 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
- 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
- Ability to occasionally lift up to 15 pounds.
- Ability to work within laboratory, manufacturing, and office environments.
- Frequent use of computers and laboratory instrumentation.
- Ability to read and interpret technical documentation.
- Must be capable of wearing required Personal Protective Equipment (PPE), including safety glasses, respirators (when required), and safety shoes.
- Must successfully complete required safety and OSHA training, including respirator fit testing.
- Ability to work in temperature- and humidity-controlled laboratory environments.
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 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.
Ready to advance your career in pharmaceutical Quality Control?
Apply today through the Ardena Careers website at careers.ardena.com and become part of a team dedicated to advancing pharmaceutical innovation and improving patient lives worldwide.