Cricket
Vijay Bangarwar
Downstream Process-Manufacturing
Pune
Summary
Dedicated Biopharmaceutical professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Overview
9
9
years of professional experience
5
5
years of post-secondary education
3
3
Languages
Work History
Executive Officer
Serum Institute of India
Pune
04.2021 - Current
- Overseeing and carrying out the downstream processing operation for the production of 4kL COVID vaccines.
- Carry out chromatography operations such as affinity chromatography, ion exchange chromatography, nanofiltration, tangential flow filtration, and final filtartion of drug substance during the manufacturing of Covavax and Covishield.
- Document preparation and completion in accordance with Good Document Practices, including SOP, BMR, protocols, and daily monitoring documents.
- Joined a team to prepare for audits of both commercial and regulatory nature.
- Submission and compliance of manufacturing batch recording in accordance with cGMP and GDP.
- Installation and qualification of equipment in accordance with the manufacturing scale
- Handling of single-use systems, including holding bags with a capacity of up to 1000 L, chromatography membranes, TFF assemblies, and single-use mixers with a capacity of up to 2000 L.
- Packing, unpacking and evaluation of chromatography columns such as axichrom columns up to 1200 mm using a column packing master and chromatography system.
- Conducted regular meetings with team to discuss issues, concerns and updates.
- Located bottlenecks to streamline existing processes.
- Identified trends and assessed opportunities to improve processes and execution.
Assistant Manager
Gennova Biopharmaceutical
Pune
10.2018 - 04.2021
- Erythropoeitin, TNK, and t-PA purifying using a variety of chromatography techniques, including affinity, gel filtration, ion exchange, TFF and final filtration.
- Document preparation and completion in accordance with Good Document Practices, including SOP, BMR, protocols, and daily monitoring documents.
- Equipment installation and qualification in accordance with the manufacturing scale
- Packing, unpacking, and evaluation of chromatography columns such as BPG and axichrom columns using a chromatography system and column packing master, respectively.
- Completed regular inventory counts to verify stock levels, address discrepancies and forecast future needs.
- Assisted in organizing and overseeing assignments to drive operational excellence.
Officer
Lupin Biotech
Pune
12.2015 - 10.2018
- Perform chromatography operations, such as affinity, mixed-mode, ion exchange, nanofiltration, tangential flow, and final filtration of drug ingredient, during the production of Enternacept (monclonal monoclonal antibody), at a scale of 1kL.
- Quickscale and chromaflow columns are packed and handled using the K-rime system and column packing master, respectively.
- Document preparation and completion in accordance with Good Document Practices, including SOP, BMR, protocols, and daily monitoring documents.
- Joined a team to prepare for audits of both commercial and regulatory nature.
- Installation and qualification of equipment in accordance with the manufacturing scale.
- Involve in QMS activity.
Officer
Gennona Biopharmaceutical
Pune
08.2013 - 12.2015
- Purification of Erythropoeitin, TNK t-PA by various chromatography technique like Affinity chromatography, Gel Filtration chromatography, Ion exchange chromatography.
- Packed and Handled BPG Columns and series XA columns with purification systems e.g. AKTA Purifier, AKTA Explorer, AKTA Pilot, and AKTA Process systems using UNICORN software.
- Performed CIP and SIP of 1 kL capcity tank.
- Preparation of buffer and solution required for process.
- Document preparation and completion in accordance with Good Document Practices, including SOP, BMR, protocols, and daily monitoring documents.
Education
Bachelor of Science - Biotechnology
Yeshwant College
Nanded, Maharashtra, India 07.2007 - 05.2010
Master of Science - Biotechnology
School of Life Sciences, SRTM University.
Nanded, Maharashtra, India 06.2010 - 07.2012
Skills
MS office expert
Process improvements
Operational leadership
Productivity performance
Staff Management
Interests
Trekking
Timeline
Executive Officer
Serum Institute of India
04.2021 - Current
Assistant Manager
Gennova Biopharmaceutical
10.2018 - 04.2021
Officer
Lupin Biotech
12.2015 - 10.2018
Officer
Gennona Biopharmaceutical
08.2013 - 12.2015
Master of Science - Biotechnology
School of Life Sciences, SRTM University.
06.2010 - 07.2012
Bachelor of Science - Biotechnology
Yeshwant College
07.2007 - 05.2010