Analytical Scientist

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.