Analytical Development Laboratory (ADL)

Job Description:

• HPLC/GC/IC method development, feasibility, verification, equivalency,
• validation for API, complex OSD products, oncology products, topical
• products having exposure to regulated, Semi Regulated & India markets Comparative evaluation of methods with alternative vender methods versus existing primary vendor and regulatory impact analysis
• Dissolution development, comparative dissolution, multimedia dissolution and statistical evaluation and report preparation
• Good understanding and hands on experience of analytical instruments like
• NI/GI & NDSRI' with LCMS/GCMS expertise, Solid state characterization and API sameness study
• Hands on experience on In-vitro Studies, E&L, Solid State characterization, IVPT/IVRT, Impurity characterization, sameness study
• Well versed with USP/EP/BP/JP and various current regulatory guidelines (ICH/EMEA/FDA)
• Perform maintenance and calibration of lab instruments/equipment.

Qualification & Experience

• M.Pharm/M.Sc
• 3 to 8 Years experience