Dynamic and versatile researcher with experience of research and documentation skills, comprehensive knowledge of all standard, regulations and operational clarity in fast paced work environment. Have excellent work ethics, motivated to perform well both individually and in a team context.
Overview
5
5
years of professional experience
5
5
years of post-secondary education
4
4
Languages
Work History
Executive
INTAS PHARMACEUTICAL (biopharm Div.)
Ahmedabad
04.2022 - Current
Scale up and process transfer for various projects.
Process development for various projects including media and parameter optimisation for both CHO and E. coli recombinant cells.
Investigated for OOS and OOT observed in processes executed in at scale batches.
Execution of upstream batches at 2L scale (glass, Sartorius), 10L scale (SS, Sartorius) for Microbial fermentation process.
Execution of upstream batches for CHO cell culture process using 5L (glass, Sartorius and Bioengineering), 50L (SUB, Sartorius and Thermo). Basic experience on AMBR 250.
Monitoring of at scale batches for microbial products at 150L and 500L scales during execution of PPQ, Trial and Commercial batches.
Monitoring of at scale batches for cell culture processes at 150, 200, 2000L scales during execution of PPQ and scale up batches.
Equipment qualification and performance verification.
Basic statistical analysis using JMP.
Documentation experience: PPQ protocol & report, Process comparability report, Investigation report, Process characterisation report, Swab recovery protocol and report to address to USFDA query, Equipment performance verification protocol & repor, SOPs, Equipment Qualification documents, QRM, Process transfer note, Change proposals to raise Change Controls etc.
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.