Analytical / QC Research Scientist （Drug Product / Drug Substance)

Job Title : Analytical / QC Research Scientist

Location : Onsite, Cranbury NJ

Position Type : Full-Time

Reports To : Director, Analytical R&D / QC

Job Summary :

We are seeking a highly motivated Research Scientist to join our Analytical R&D and QC department within the CDMO (Contract Development and Manufacturing Organization) industry. The ideal candidate will have a strong background in analytical chemistry and experience in method development, validation, and quality control testing.

Key Responsibilities :

• Conduct analytical method development and validation independently.
• Troubleshoot analytical methods as needed and gain more experience in the related area.
• Conduct release testing for GMP regulatory starting materials, intermediates, and final APIs.
• Conduct testing for stability studies and cleaning verification.
• Review test data to ensure completion and accuracy.
• Write raw material test procedures as needed under supervision.
• Write SOPs and protocols as needed under supervision.
• Write instrument operating, maintenance, and qualification / calibration procedures as needed.
• Participate in OOS and deviation investigations, as needed.
• Support Quality Assurance as needed during internal audits and audits by clients and regulatory agencies. Assist in the development and implementation of corrective actions related to QC / AD.
• Troubleshoot and maintain analytical instruments. Ensure that instrument calibration and qualification intervals are current.
• Perform structural elucidation of small molecule drug substances, intermediates, and starting materials.
• Independently troubleshoot and resolve issues with NMR instrumentation.
• Provide clear oral and written explanations of NMR data for structural elucidation
• Identify and elucidate the structures of related impurities and degradants from API synthesis, fate and purge, and stress degradation studies.

Qualifications :