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:

• BS, MS, or PhD in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related field.
• 3+ years of experience in analytical R&D and/or QC within the pharmaceutical or CDMO industry.
• Strong knowledge of analytical techniques, including HPLC, GC, UV-Vis spectroscopy, and dissolution testing.
• Familiarity with method validation protocols and regulatory requirements.
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
• Proficient in data analysis software and laboratory information management systems (LIMS).