AMLAN ASHUTOSH MISHRA
Ahmedabad
Summary
To work in a dynamic environment that enables me to utilise my knowledge and learn new things and to progress professionally and personally. I see myself as a hardworking, self-motivated and organized individual who has more that 6 years of Upstream process experience along with technical documentation knowledge. Having a demonstrated expertise on process optimization, skilled in ensuring compliance and proper planning with a knack for driving projects to completion by commitment, excellence and team collaboration, ready to take on new roles and opportunities.
Overview
6
6
years of professional experience
Work History
Senior Executive
INTAS PHARMACEUTICAL (biopharm Div.)
Ahmedabad
04.2022 - Current
- Process optimization for improvement of productivity and quality profile for various projects of Mammalian and Microbial cell culture based products.
- Process scale up.
- Perform upstream batches for CHO cell culture at Shake flasks, AMBR 250, 5L bioreactors (Glass) and 50L bioreactors scale (SUB).
- Perform upstream batches for E coli cell culture at Shake flasks, 2L fermenter (Glass) and 10L fermenter scale (SS).
- Perform cell bank evaluation studies for various Mammalian cell culture projects.
- Prepared E coli cell banks (UCB).
- Perform batches using 5L wave bioreactor using perfusion method for process intensification in CHO cell culture.
- Perform high cell density batches to increase biomass and IB output in E coli at 10L scale.
- Monitor and support during execution of scale up, engineering and PPQ batches of CHO Cell culture process at manufacturing at 200L, 1000L, 2000L, 4000L and 5000L scales.
- Monitor and support during execution of scale up, PPQ and protocol based batches of E coli process at manufacturing at 150L and 500L scales.
- Generate NPEL of harvest samples for N Glycan and CEX analysis.
- Review and prepare technical documents such as PPQ protocol and report, process transfer notes, process comparability report, Process development reports, equipment qualification and performance verification protocols, cell bank evaluation protocol and report, QRM etc.
- Investigated at scale batches with deviation and OOS to find out possible outcomes.
- Perform Equipment qualification and performance verification.
- Basic statistical analysis using JMP software.
- Review LNBs, BPCRs, equipment log books to ensure compliance and maintain lab ethiquettes.
- Prepare SOPs and change proposals to support team for QMS related activities.
- Have performed kLa studies.
- Planning and execution of engineering batch based on protocol.
- Presenting technical sessions
Research Asoociate
Lupin Biotech
Pune
04.2019 - 04.2022
- Execution of developmental batches at 2L, 5L and 10L scale using recombinant E. coli.
- Scale down and process characterization studies.
- SOP preparation.
- Development and implementation of new upstream processes.
- Qualitative analytical experience using SDS PAGE.
- Preparation of BPR for scale up.
- Process monitoring and troubleshooting.
Education
Masters in Science - Biotechnology
Ravenshaw University
CuttackBachelor of Applied Science - Biotechnology
BJB Autonomous College
Bhubaneswar Skills
Planning and execution
Compliance
Documentation
Upstream process development
Presentation
Time management
Ownership
Teamwork
Awareness of project deadline
Languages
English
Proficient
C2
Hindi
Proficient
C2
Odia
Proficient
C2
Alternative contact details
7383781338 (on weekdays from 8-5)
Because of mobile restrictions, I will not be able to answer on 7377420004 number, but I can answer on 7383781338.
Thanks for your understanding.
Timeline
Senior Executive
INTAS PHARMACEUTICAL (biopharm Div.)
04.2022 - Current
Research Asoociate
Lupin Biotech
04.2019 - 04.2022
Masters in Science - Biotechnology
Ravenshaw University
Bachelor of Applied Science - Biotechnology
BJB Autonomous College