Brij Kishor Rai

To obtain a responsible position within a progressive organization, where I can utilize my skills, ability and education in finding opportunities for professional growth and career advancement.

• Leading project of generic molecules with a team of API analytical group.
• Frequently execute Analytical method development approach by using Dry Lab software.
• Plan & execute impurity control strategy as per ICH Q3A (R2) & GTI impurity as per ICH M7 (R2).
• Design the specification of raw material, Intermediates & final API.
• Carryover study for DMF filing readiness.
• Transfer the Analytical methods to GMP sites (manufacturing unit or production plan) in Czech Republic, Croatia, Hungary & India.
• Prepare technology transfer protocol & report of analytical methods.
• Prepare & review STP of different analytical method like Impurity profile (related substances), Assay, content and titration.
• Review & prepare Certificate of analysis (COA) reference standard, working standard & different impurity standards of API, Intermediates & Raw material.
• Method development and validation of various methods for API, SM and intermediates by HPLC.
• Preparation of Analytical control, MOA, protocol, report and documentation related to validation of drug substance for RS, Assay & Content method by HPLC.
• Prepare Protocol & report of stability study of API at R&D site.
• Perform investigation of unknown impurity in samples by QDA Mass Analysis.

• English
• Hindi
• Bhojpuri

• HPLC (Agilent, Shimadzu, Waters & Dionex) with Chromeleon as well as Empower software.
• UPLC (Waters & Agilent) with empower software.
• Ion chromatography (Dionex with Chromeleon & Metrohm with MagIC Net software).
• Prep-HPLC (Gilson with trilution software).
• MS and QDA (Waters).
• PH meter (Labindia, Metrohm & Mettler Toledo).
• Karl Fischer Apparatus (Metrohm and Mettler Toledo).
• FTIR (Mettler Toledo).
• UV/VIS Spectrophotometer (Shimadzu).
• Melting point apparatus.
• Wet lab analysis (Titration, Solubility ROI & Loss on dry).

• Father's Name: Mr. Khakhan Rai
• Date of Birth: 01/26/87
• Gender: male
• Nationality: Indian
• Marital Status: Married