Analytical R&D Scientist II

R&D Chestnut Ridge, New York


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Analytical R&D Scientist II – Chestnut Ridge, NY: Perform analytical method validations/verifications under moderate supervision for raw materials and finished products. Write/review analytical test methods, validation/verification protocols, and reports. Troubleshoot OOS results. Conduct routine and non-routine laboratory analyses such as raw materials, finished product testing, stability testing, and manufacturing in-process testing, which requires critical levels of accuracy. Analyze and interpret results in written and oral format in consultation with supervisor/project leaders. Follow all SOPs and Safety Guidelines and work in compliance with cGMP/cGLP regulations. Maintain R&D lab as a GMP-compliant and safe working environment. Ensure notebooks reviewed in a timely manner, in accordance with SOPs. Review laboratory notebooks, raw data and testing results to ensure accurate documentation if required. Document analytical data under cGMP and corporate guidelines. Provide general lab support: routine instrument cleaning/preventive maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping. Keep the training record related to the job functions up to date and make sure one receive proper training before performing any tests. Applicant must have a Master Degree in Pharmaceutical Science or Pharmaceutical Manufacturing. Must have 2 years of experience working as research an Associate in a Pharmaceutical Company handling laboratory functions. Must have experience in HPLC and GC based analytical methods: assay, Chiral Purity, Residual Solvents, Dissolution, Water Content FTIR; Operating, Calibrating, Troubleshooting HPLC, GC, UV/VIS, Dissolution Apparatus, FTIR, and Karl Fischer Titrator, PH Meter and Analytical Balance. Must have experience of working in compliance with SOP, CGMP, FDA, ICH, DEA, OSHA and DEA Regulations, MSDS, USP, EP and JP. 40 hours per week, M-F 9:00am-5:00pm. Must have proof of legal authority to work in the United States. Mail resumes to HR at Par Pharmaceutical, 6 Ram Ridge Road, Chestnut Ridge, NY 10977. Job Ref. #20190315.