Analytical Scientist

5 days ago


New Delhi, India PI Health Sciences Ltd Full time

Qualifications & Experience:- M.Sc. in Analytical Chemistry, Pharmaceutical Sciences, or a related field. - 3-5 years of experience in analytical R&D within a CDMO, pharmaceutical, or biotechnology company.Key Responsibilities:- Develop, validate, and transfer analytical methods for raw materials, intermediates, and finished products in compliance with regulatory guidelines (ICH, USP, EP, JP, etc.). - Perform method development using techniques such as HPLC, UPLC, GC, MS, FTIR, UV-Vis, and dissolution testing. - Support formulation development by providing analytical data for stability, compatibility, and process optimization studies. - Troubleshoot analytical methods and instrumentation to ensure data integrity and reliability. - Conduct forced degradation and stability studies to establish product shelf life. - Prepare and review technical documents, including protocols, reports, SOPs, and regulatory submissions (IND, NDA, ANDA, DMF). - Collaborate with R&D, quality control, and regulatory teams to support drug development projects. - Maintain compliance with GMP/GLP and other regulatory requirements during method development and validation. - Stay updated with advancements in analytical technologies and regulatory changes to enhance laboratory capabilities.


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