AR&D Chemist

Quagen Pharmaceuticals; New Jersey; On-site; USD 55,000 - 75,000; Full time

Job summary

Quagen Pharmaceuticals is seeking an Entry-Level AR&D Chemist to support analytical method development, validation and testing for drug substances and products in a GMP environment.

The role requires a strong foundation in analytical chemistry, attention to detail, and collaboration with cross-functional teams while adhering to cGMP and data integrity principles. Training will cover HPLC/UPLC/GC, dissolution and related assays in a regulated setting.

Qualifications

• Bachelor’s or Master’s degree in a related science.
• 0–2 years in a pharmaceutical AD/QC lab or regulated lab.
• Fundamental knowledge of cGMP, GLP and data integrity.
• Strong problem-solving and communication skills.

Responsibilities

• Perform routine and non-routine analysis of APIs, excipients, and finished dosage forms using analytical techniques such as HPLC, UPLC, GC, Dissolution, UV, FTIR, KF, and other laboratory instrumentation.
• Assist senior scientist in method validation and verification activities following approved protocols and current ICH guidelines.
• Support senior scientists in the development, optimization, and transfer of analytical methods.
• Perform stability sample testing, record results, and support stability studies and data trending activities.
• Maintain accurate laboratory notebooks, test records, analytical reports, and electronic data in compliance with cGMP and data integrity requirements.
• Adhere to laboratory procedures, standard operating procedures (SOPs) and applicable regulatory requirements.
• Perform other duties assigned commensurate with position.

Skills

Detail-oriented

Analytical thinking

Communication skills

Team collaboration

Education

Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Pharmacy

Tools

HPLC

UPLC

GC

Dissolution testing

UV/Vis spectrometry

FTIR

Job description

We are seeking a highly motivated and detail-oriented Entry-Level AR&D Chemist to join our growing pharmaceutical research and development team. This role is responsible for supporting analytical method development, validation, and testing activities for drug substances and drug products in a pharmaceutical development environment. This role requires a strong foundation in analytical chemistry, attention to detail, and the ability to work collaboratively with cross-functional teams while following cGMP requirements.

Key Responsibilities

• Perform routine and non-routine analysis of APIs, excipients, and finished dosage forms using analytical techniques such as HPLC, UPLC, GC, Dissolution, UV, FTIR, KF, and other laboratory instrumentation.
• Assist senior scientist in method validation and verification activities following approved protocols and current ICH guidelines.
• Support senior scientists in the development, optimization, and transfer of analytical methods.
• Perform stability sample testing, record results, and support stability studies and data trending activities.
• Maintain accurate laboratory notebooks, test records, analytical reports, and electronic data in compliance with cGMP and data integrity requirements.
• Adhere to laboratory procedures, standard operating procedures (SOPs) and applicable regulatory requirements.
• Perform other duties assigned commensurate with position.

Qualifications

• Education: Bachelor’s (B.S.) or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Pharmacy, or related scientific discipline.
• Experience: 0–2 years of experience in a pharmaceutical AD/QC laboratory or regulated laboratory environment.
• Basic understanding of cGMP, GLP, laboratory documentation, and data integrity principles.
• Strong problem-solving, organizational, and communication skills.