Experience
Mylan Pharmaceuticals Pvt.
Ltd., Global Biologics R&D, Hyderabad - July 2013 - Present (9
months)
Designation:
Assistant General Manager
· Establishment of Functional Characterization
laboratory at Mylan Global Biologics R&D for bio-therapeutics product
characterization.
· Managing by overseeing, reviewing and
troubleshooting, biosimilar development programs of Mylan with collaborator.
· Leading the efforts of functional characterization
of bio-therapeutic drugs for regulated markets.
Dr. Reddy's Laboratories,
Biologics Division, Hyderabad - May 2010 - July 2013 (3 year
3 months)
Designation: Principal Scientist - January
2012 – July 2013 (1 year 7
months)
· Led the efforts for functional
characterization of
bio-therapeutic drugs for regulated markets (IND for FDA and IMPD for EMEA).
· Established a comprehensive package for IND
submission of a mAb with assays for all known MOA’s (CDC, ADCC and Apoptosis)
and various binding assays for characterization of different domain of mAb
(Ligand binding through CDR, C1q binding, Fcgamma receptor binding and FcRn
binding)
· Developed platform based approach for
characterization of functional activity of various mAb. These platforms (ADCC
assay, competitive ligand binding assay and Fcgamma binding assay) were
successfully implemented in more than one bio-therapeutic mAb.
· Establishment of Structure Function Relationship for
bio-therapeutic products especially therapeutic monoclonal antibodies.
· Validation and technology transfer of biological
assays to QC and labs outside DRL.
· Also developed and qualified Clinical ADA assays for
bio-therapeutic products.
Designation: Senior Scientist - May 2010
- December 2011 (1 year 8
months)
· In depth functional characterization of various
bio-therapeutic products especially therapeutic monoclonal antibodies
· The focus was primarily on establishment of Structure
Function Relationship which helped in product/process development.
Intas Biopharmaceuticals,
Ahmedabad - January 2009 - April 2010 (1 year 4 months)
Designation: Scientist-I
· Development of novel Bio-assays and establishment of
flow cytometer based platform for functional characterization of bio-therapeutics
drugs to support IMPD filing for EMEA
Cadila Pharmaceuticals
Limited, Ahmedabad - April 2008 - January 2009 (10 months)
Designation: Senior Manager
· Development of cell based bio-assay for evaluating
potencies of in-house bio-therapeutics products
· Development of In-vitro
cell based assays for vaccine based project
· Establishment and characterization of novel cancer
cell lines from the primary human tumor tissues
ReaMetrix India Pvt. Ltd,
Bengaluru - December 2005 - April 2008 (2 years 5 months)
Designation: Project Leader
· Development of Flow Cytometer based Immuno assays
for diagnostic application (HIV, Platelets and Leukemia Lymphoma
Characterization)
· Business Development & Customer support
(Customer Interaction, Customer training, and troubleshooting at Customer site)
· Clinical Validation Management for the developed
assay at clinical sites using clinical samples.
· Manufacturing Manager for diagnostic reagents (secondary
responsibility)
Hindustan Lever Limited,
Bengaluru - June 2001 - December 2001 (7 months)
Designation: Research Officer
· Worked towards establishment of the Antisense-RNA
techniques in the Cell Biology lab using B16-F1 mouse melanoma Cells
· Established the role of vitamins in skin
pigmentation (Filed patent application)
