Job
Description
Qualifications & Experience: Master’s or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field. 3-8 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. Show more Show less
