Job Description

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

t.
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

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