Scientist – Quality Control; QC

Scientist – Quality Control (QC) at Ardena 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.

Location:

Somerset, New Jersey

FLSA Status:
Exempt

Employment Type:

Full‑Time

• Perform analytical testing of raw materials, in-process materials, finished products, and stability samples.
• 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:
  • 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 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, and Electronic Laboratory Notebooks (ELN).
• Strong organizational, analytical, and problem‑solving skills.
• Excellent verbal and written communication skills.
• Ability to 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 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 offers an international working environment that encourages development, ownership, and career growth across functions and locations. Benefits 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.