Biopharmaceutical

Created 3 years ago in Industries / Other

• Over 30 years of experience in the Pharmaceutical Industry
o Demonstrated record of accomplishment in developing manufacturing processes for clinical trial material & commercial supplies.
o Experienced in authoring & reviewing CMC documents for regulatory submissions (6 launched products).
o Detailed hands-on experience in technology-transfer and managing technical aspects of projects at contract manufacturing sites located around the world.
• Strategic Thinker with Tactical Leadership Skills
o Leadership role in setting strategic path & growth of GSK’s Bio-Pharmaceutical CMC Division.
o Demonstrated ability to lead multi-disciplinary scientific & technical teams.
o Proven ability to articulate a long-term vision and set strategic goals with the discipline and focus to implement tactical plans
• Technical Expertise
o Technically trained in cellular physiology and molecular biology with experience encompassing Drug Discovery and Development.
o Thorough knowledge of various heterologous gene expression technologies and platforms ranging from coli to yeast to mammalian cells.
o Experienced in all aspects of drug discovery, including target selection, assay design, HTS/UHTS, lead identification, SAR analysis and lead optimization.
o Four issued patents + Over 25 peer reviewed published articles
o Co-author of the A-mAb case study for the application of QbD principles & served on GSK’s committee assisting the advisory board for ICH-11 concept paper. GSK’s sponsor on industry consortia viz. BioPhorum and NIIMBL.