Team Led activities for process development, scale-up, and clinical manufacturing of proteins and purification operations for recombinant proteins produced in microbial systems. Design of process in co-ordination with down stream process. Monitoring production facility plans & Working in co-ordination with projects team in commissioning new cGMP facility for production [up scaling]. Planned, supervised, and performed development activities for more IB recovery and purification by performing small-scale experiments to evaluate and optimize process alternatives for clarification and purification of protein products [IBs]. Optimization of clarification, concentration & diafiltration of crude proteins solutions using micro & ultra filtration methods. Developed and implemented analytical tools for evaluating protein quality, quantifying product impurities, and supporting fermentor and media development-groups. Communicated with outside collaborators and vendors to move projects forward and implement current practices. Discussed project direction and presented experimental results, manufacturing outcomes, and technical seminars to all levels of management and personnel throughout the company and with collaborators. Authored SOPs, Batch Production Records, and technical reports for approval from RCGM for toxicology studies.

 Responsible for overall vaccine projects in R&D and Production. a. Process verification and process optimization of Hib and Typhoid vaccine projects.b. Responsible for Technology transfer for both Hib and Typhoid Project. c. Responsible for Analytical method validation for Hib and Typhoid project.d. Process development for Typhoid – Tetanus toxoid conjugate. e. Development for different formulation for Pantavalent Vaccine

Worked in project is supported by WHO and PATH (Program for Appropriate Technology in Health) and funded by The Bill & Melinda Gates Foundation.• KEY RESPONSIBILITIES: i) Scale up, purification, research and development and cGMP production of polysaccharide vaccines. Scale Up Hib 74g to 300g Scale Purification Hib and Men-A Crud polysaccharide R&D Pneumococcal project ii) Preparing process related documents such as BMR’s, SOP’s and production trend analysis.iii) Interacting and coordinating with quality assurance and quality control for smooth operation of production.iv) Root cause analysis and trouble shooting in case of batch failure.

 Part of the successful team that the Process development/Process verification of Hib project at R&D. Part of successful team which Purification Process development for Meningococcal A. • KEY RESPONSIBILITIES:The major projects handled include:a) Meningococcal vaccine [A, C, Y&W135]. Having experience on DSPb) Haemophilus influenzae type b conjugate vaccine with tetanus, which has a tech, Transfer form NVI, Netherlands. I had the opportunity to be trained at NVI for one month on Fermentation, DSP & CONJUGATION strategies involved in polysaccharide vaccines.c) Pnemococcal conjugation vaccine in the stage of technology transfer process.• PROFESSIONAL ACHIEVEMENTSd) Extraction and Purification of polysaccharide.e) Successfully prepared the clinical trials materiel.f) Imparted training in Netherlands Vaccine Institute (RIVM) for fermentation, down streaming and conjugation.g) Low Endotoxin level in purified Polysaccharide (<2EU).h) High expression levels in conjugation of Hib, MenA, Pneumococcal Polysaccharides with alternative technology. i) Conjugation of polysaccharide with tetanus toxoid using different chemical Methods.j) IPQC testing.k) Prepared documentation for product scale-up (URS, Risk assessment) as well as SOP & BMR for Hib production.l) Established a new lab facility, working area for Pneumococcal Conjugation.

 Worked in H. Pylori and Liver Transplantation Project.• Key responsibilities: isolation of: Stem cells from features. RNA form stem cells. DNA from Helicobacter Pylori.

 Worked as for sustain relies drug in from September 2000 to 2002.Mainly focus on blending and packing section.