Associate Director, Asset Head MSAT Cell Therapy - Lonza Houston - Houston
(2024-08)
- Strategic Business partner representing CT MSAT across CT business and operations activities at Lonza Houston Commercial facility.
- Responsible for supporting new client acquisitions, on boarding new business and leading technology transfer activities and process improvements for early to commercial programs.
- Leading Technology Transfer team for all Cell Therapy Programs
- Interface between higher management, Business Unit and SME teams.
- Experienced in supporting IND, BLA, PAI and other regulatory support in Cell Therapy.
- Supported onsite client and regulatory body audits including FDA.
MSAT Manager, Cell Therapy - Lonza Houston - Houston
(2022-08)
- Managing team of scientists to execute Cell Therapy Tech Transfer activities to MFG including early phase to commercial phase programs.
- Leading and facilitating local and global initiatives to facilitate New Product introduction for early to late phase cell therapy programs.
MSAT Senior Scientist, Cell Therapy - Lonza Houston - Houston
(2021-08 - 2022-07)
- Support Cell Therapy Tech Transfer activities to MFG.
- Leading and Facilitating Tech transfer of Phase III autologous CART Cell therapy to MFG.
MSAT Scientist III, Cell Therapy - Lonza Houston - Houston
(2020-08 - 2021-08)
- Support Cell Therapy Tech Transfer activities to MFG.
- Involved in leading and Facilitating Tech transfer of Phase III autologous CD34 Cell therapy to MFG.
- Involved in leading and facilitating Tech Transfer of Phase I CAR-T therapy to MFG.
Senior Scientist, Viral Vector and Gene therapy, Upstream PD - Fujifilm Diosynth Biotechnologies
(2018-08 - 2020-08)
- Lead and managed multiple client projects for tech transfer to cGMP manufacturing of preclinical, Phase I and phase III stages.
- Well versed with scale –up for adherent as well as suspension cultures using several different platforms such as cell stacks and XDR bioreactors respectively for products ranging from cell banks to AAV vector production.
- cGMP generation of Master cell banking of normal and iPSCs.
- Cell Line Development for Viral Vector production.
- Lead and managed direct line reports consisting of a team of three scientists and matrix managing several others.
- Involved in client meetings such as kick offs, onsite visits and joint team meetings for project updates.
- Authored SOP, Batch records, formulation records, change controls and other documentation.
- Involved in initiating and closing of Deviations and CAPA using Trackwise.
Senior Scientist, Monoclonal Antibody Manufacturing, Design and development - Ansh Labs - Webster, TX-77598
(2014-08 - 2018-07)
- Started new department for upstream and downstream scale up of monoclonal antibodies required for manufacturing of in vitro immune diagnostic kits.
- Designed and developed monoclonal antibodies by hybridoma generation.
- Involved in generating novel recombinant proteins/analytes and monoclonal antibodies using molecular biology and cell line engineering methodologies.
- Developed novel immune assays for metabolism related analytes such as Oxyntomodulin and Glucagon.
- Established QCS criteria according to ISO and FDA standards.
- Started new molecular biology laboratory for antibody engineering.
- Managed the production needs of the entire company using Celligen 115 Bioreactor and roller bottle techniques.
- Designed, engineered and developed antigen and antibody expression platforms in stable and transient systems such as CHO.S and HEK293F.
- Managed direct reports.
- Involved in and managed ISO and FDA audits.
- Experienced in writing SOP, MWI, QCS, technical reports etc.
- Authored several abstracts presented at international and national meetings involved in developing of new products through ELISA.
Postdoctoral fellow - MD Anderson Cancer Center
(2012 - 2014)
Established Xenopus egg extract system to study epigenetic inheritance during DNA replication.
Postdoctoral associate - Baylor College of Medicine
(2010 - 2012)
Established ubiquitination assays and identified novel protein interactions during DNA damage and repair.
Graduate Student - UTHSCSA - San Antonio, TX
(2004 - 2009)
Developed a novel Xenopus egg extract system to study Nucleotide Excision repair in vitro.
Graduate Research Assistant - UTHSCSA - San Antonio, TX
(2002 - 2004)
Student Research Assistant - Georgia State University - Atlanta, GA
(2001 - 2002)
Research Trainee - International Crop Research Institute for Semi-Arid Tropics - Hyderabad, India
(2001 - 2001)
