AR&D Scientist II
quagen pharmaceuticalsCaldwell (NJ)
About the role
About the Role:
Join our expanding AR&D team as an AR&D Scientist II. This role is responsible for method development, validation, and analytical support activities for both drug substances and drug products in a dynamic, fast-paced environment. This role requires strong technical proficiency in chromatographic and spectroscopic techniques, combined with a solid grasp of regulatory requirements. Mentor and guide junior scientists while collaborating closely with cross-functional teams in Formulation, QC, Regulatory, and Manufacturing.
Responsibilities:
Develop and optimize analytical methods (HPLC, UPLC, GC, Dissolution, UV, FTIR, KF, ICP, PSD, IVRT/IVPT etc.) for APIs and finished dosage forms. Perform and document method validation per USP and ICH guidelines. Design and execute stability-indicating methods; support stability protocol creation and data review. Maintain and troubleshoot analytical instruments; ensure calibration and qualification compliance. Review and approve analytical data, notebooks, and reports under GMP/GLP expectations. Provide analytical support to formulation development, scale up, and tech transfer. Perform other duties assigned commensurate with position.
Qualifications:
Master’s or Ph. D. in Chemistry, Pharmaceutics, or a related scientific discipline.5+ years of analytical development experience, with a proven track record in the pharmaceutical industry. Deep understanding of cGMP with hands-on experience writing quality investigations. Proficient in using Empower Chromatography software including custom field calculations. Strong math skills, clear communication, and proven capability to work productively both independently and within collaborative teams.
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