Sr. Research Scientist (Analytical DS &DP)

Job Title: Sr. Research Scientist (ARD/QC)

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

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Key Responsibilitie

• s:Conduct analytical method development and validation independentl


• y.Troubleshoot analytical methods as needed and gain more experience in the related are


• a.Conduct release testing for GMP regulatory starting materials, intermediates, and final API


• s.Conduct testing for stability studies and cleaning verificatio


• n.Review test data to ensure completion and accurac


• y.Write raw material test procedures as needed under supervisio


• n.Write SOPs and protocols as needed under supervisio


• n.Write instrument operating, maintenance, and qualification/calibration procedures as neede


• d.Participate in OOS and deviation investigations, as neede


• d.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/A


• D.Troubleshoot and maintain analytical instruments. Ensure that instrument calibration and qualification intervals are curren

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Qualificatio

• ns:BS, MS, or PhD in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related fie


• ld.3+ years of experience in analytical R&D and/or QC within the pharmaceutical or CDMO indust


• ry.Strong knowledge of analytical techniques, including HPLC, GC, UV-Vis spectroscopy, and dissolution testi


• ng.Familiarity with method validation protocols and regulatory requiremen


• ts.Excellent problem-solving skills and attention to deta


• il.Strong communication and interpersonal skills, with the ability to work effectively in a team environme


• nt.Proficient in data analysis software and laboratory information management systems (LIM