Sr. Research Scientist (Analytical DS &DP)

Location: Onsite, Cranbury NJ

Position Type: Full-Time

Reports To: Director, Analytical R&D/QC

Job Summary: We are seeking a highly motivated Sr. 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.

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).