Deputy Manager-Manufacturing Technology
Shantha Biotechnics Limited
Total des années d'expérience :19 years, 5 Mois
Recombinant Protein and Vaccine Production, Primary purification and characterization from bacterial and yeast expression systems, Bio Process Optimization (upstream and primary downstream), Scale-up and Tech-transfer and Technical support.
- Currently associated with Shantha Biotechnics Limited (A Sanofi Company), Hyderabad (India) as Deputy Manager (Manufacturing Technology).
Areas of Expertise
* Quality practices - GLP and GMP
* Bioprocess Optimization, Scale-up and Validation studies for manufacturing of Clinical Phase Products - Vaccines, Therapeutic Proteins
* Microbial Fermentation- Batch and Fed-Batch fermentation process optimization and Troubleshooting
* Primary downstream process: Cell disruptions and Membrane Filtrations techniques (TFF)
* Protein Analysis and Characterization
* Media optimization, process raw material qualifications
* Cell bank preparation and characterization
* Basic and applied microbiological techniques
* Quality Documentation Systems ( Development of Protocols, SOPs, BPRs, study designs, MFR, Process Validation, Technical Reports, Technology Transfer)
Experience Chronology
Since October 2006 with Shantha Biotechnics Ltd. (A Sanofi Company), Hyderabad, India (Indian biotechnology company based in Hyderabad, wholly owned Subsidiary of Sanofi group and manufacturing recombinant human healthcare products-Vaccines)
Growth Path:
Apr 2013 - Present : Deputy Manager (Manufacturing Technology)
Apr 2012 - Mar 2013 : Scientist I (R&D)
Apr 2010 - Mar 2012 : Associate Scientist (R&D)
Oct 2006 - Mar 2010 : Senior Research Associate (R&D)
* Planning and execution of experiments to develop and optimize fermentation (batch& fed batch) and primary downstream process for human vaccines and therapeutic by using recombinant and wild microbial strains (Bacterial and yeast expression system). Characterizing the microbial behavior to optimize growth and productivity.
* Preparation and maintaining of microbial stock cultures for research and industrial application.
* Scale-up of process from lab scale to pilot scale and technology transfer to cGMP production scale manufacturing.
* Leading activities related to microbial fermentation process development and providing technical support to commercial process development.
* Process data collection, compiling, documentation and analysis of experimental results.
* Developing and writing of protocols, SOPs, BPR, MFR, study design, technical reports, and other quality documents.
* Effectively collaborate with peers and share ideas and solutions regarding ongoing projects. Applying technical concepts and experience to complete projects.
* Engaged in projects for process development of vaccines (WCP, TT, HIB-PRP, ACP, Typhoid-Vi vaccine, Oral Cholera vaccine and recombinant HBsAg, GCSF and HPV vaccine)
December 2003 to October 2006 with SPIC Science Foundation-Center for Biotechnology, SPIC Ltd. Tuticorin & Chennai-India, as Junior Research Fellow
(Indian company based in Chennai, wholly owned Subsidiary of SPIC group and involving in contract research of Biotechnology & life science projects and manufacturing of Enzymes, Biopharma products& fertilizers)
* Screening of Industrially important microorganism from various sources and their identification, characterization and maintenance for further studies.
* Screening of microorganisms for the production of industrially important enzymes and other bioproducts.
* Optimization of upstream and downstream -bioprocess at lab scale and pilot plant level.
* Preparation of host competent cells and vectors, Primer designing, DNA amplification by PCR method and their application in r-DNA Technology.
* Selection and identification of clones/ recombinant microorganisms.
* Scientific data management and documentation of results. Collection and analysis of technical and research literature.
Screening of Industrially important microorganism from various sources and their identification, characterization and maintenance for further studies.
Screening of microorganisms for the production of industrially important enzymes and other bioproducts.
Optimization of upstream and downstream - fermentation process in lab scale and pilot plant level.
Bioproduct identification and purification by biochemical and molecular biological methods.
Strain improvement by conventional and Site Directed Mutagenesis methods to modify the microbes as industrially most suitable one.
Microbial analysis and quality control of bioprocess and final product.
Screening of herbal extracts for antimicrobial compounds and their further improvement as biocontrol agents in various application.
Isolation of Plasmid, Chromosomal DNA, and RNA from microbial source and their identification and application in various molecular biological techniques.
Preparation of host competent cells and vectors, Primer designing, DNA amplification by PCR method and their application in r-DNA Technology.
Selection and identification of clones/ recombinant microorganisms.
Scientific data management and documentation of results.Collection and analysis of research literature by various sources.