AR&D Scientist II

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.