Brij Kishor Rai
Greater Noida
Summary
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.
Overview
13
13
years of professional experience
Work History
Analytical Project lead -J10
Teva API Pvt. Ltd.
Greater Noida
09.2021 - Current
- Company Overview: (R&D centre Greater Noida Uttar Pradesh)
- 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.
- (R&D centre Greater Noida Uttar Pradesh)
Senior Research Scientist
Fresenius Kabi Oncology ltd.
Gurgaon
08.2016 - 09.2021
- Company Overview: (Innovation and development centre, Plot11, Sector 32, Gurgaon, Haryana)
- (Innovation and development centre, Plot11, Sector 32, Gurgaon, Haryana)
Senior Chemist
Mylan laboratory limited
Hyderabad
09.2014 - 07.2016
- Company Overview: (R&D Centre Bollaram, Hyderabad)
- (R&D Centre Bollaram, Hyderabad)
Research Associate
Lupin Limited
Pune
09.2012 - 09.2014
- Company Overview: (Lupin Research Park, Pune, Maharashtra)
- (Lupin Research Park, Pune, Maharashtra)
Education
M. Sc. - Pharmaceutical Chemistry
Jiwaji University
Gwalior, M.P., IndiaB. Sc. - Biotechnology
Jiwaji University
Gwalior, M.P., IndiaIntermediate of Science -
BIEC Patna
Patna, Bihar, IndiaMatriculation -
BSEB Patna
Patna, Bihar, IndiaSkills
- Team work
- MS Office (Word, Excel, PowerPoint)
- Communication skills
- Leadership
- Problem-solving
- Teamwork & collaboration
- Adaptability
- Time management
- Creativity
- Critical thinking
- Decision-making
Roles And Responsibilities
- 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.
Addresses
Vill-Sisai P.O.-Dumarsan Bangra, Dist-Saran, Bihar, 841410, India, Flat No.-1012, Tower-B, Gaur Atulyam Society, Omicron1, Greater Noida, Uttar Pradesh, 201310, India
Computer Exposure
DOS, Windows 9x/XP, Microsoft Office, Web based application
Technical Competencies - Summer Internship
Ipca Laboratory Limited, Kandivali West, Mumbai, HPLC Method development for reaction monitoring and test of API, GC & Wet Analysis, 3 Months, 06/01/12, 08/30/12
Languages
- English
- Hindi
- Bhojpuri
Instruments Used
- 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).
Personal Information
- Father's Name: Mr. Khakhan Rai
- Date of Birth: 01/26/87
- Gender: male
- Nationality: Indian
- Marital Status: Married
Languages
Hindi
First Language
English
Upper Intermediate
B2
Bhojpuri
Proficient
C2
Timeline
Analytical Project lead -J10
Teva API Pvt. Ltd.
09.2021 - Current
Senior Research Scientist
Fresenius Kabi Oncology ltd.
08.2016 - 09.2021
Senior Chemist
Mylan laboratory limited
09.2014 - 07.2016
Research Associate
Lupin Limited
09.2012 - 09.2014
M. Sc. - Pharmaceutical Chemistry
Jiwaji University
B. Sc. - Biotechnology
Jiwaji University
Intermediate of Science -
BIEC Patna
Matriculation -
BSEB Patna
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