Ganesh babu kolakaluri
Gachibowli, Hyderabad
Summary
Carrying an experience of 16yrs in Upstream Microbial fermentation, optimization, Process development, Scale Up and Tech transfer minded Process Development with experience in managing process development for new product manufacturing techniques in the organic chemicals industry. Comfortable working with mega teams across multiple time zones and an expert on simulation and optimization techniques. An exceptio nal track record for zero error tolerance relating to scoping
Overview
17
17
years of professional experience
Work History
Deputy Manager, Upstream Process development
Indian Immunologist Ltd
10.2015 - Current
- Applied cGMPs to process development and scaleup
- Recommended innovative technologies and conducted experiments for evaluation and implementation.
- Prepare/review technical documentsincluding development /tech transfer reports,batch records, SOPs and CMC regulatory submissions
- Recommend innovative new technologies and perform the necessary experiments for evaluation, implementation and writing scient ific publications
- Spearheaded an FMEA study and carried the resulting replacement of gaskets, valves, an d diaphragms for process equipment such as Reactors, Portable Tanks,Westfalia centrifuges, Millipore TFF Skid and chromatography Packed column.
- Reviewed internal IQ, OQ, PQ documentation. Assisted with validation execution and approval of documentation.
- Evaluated data on manufacturing process leading to product yield and reliability enhancement, resulting in substantial burn-in reduction.
- Drove innovation and continuous improvement through laboratory experiments evaluating new bioprocess technologies.
- Preparation of URS and executionof Equipment qualifications (IOQ).
- Design and execution of experiments to increasethe yield and quality.
- Develop and implement molecular cell biology tools or assays to characterize cell physiology changes and correlate to cell cultureperformance or product quality attributes
- Work in collaboration with colleagues in pilot and manufacturing scale operations to devise scale-up strategies forfermentation processes. Providetechnical guidance in scale up programs basedon risk assessment of criticalparameters and their impact on product qualityattributes
- Reviews laboratory worksheets and batch records
- Perform development, scale up and transfer of and purification processes to GMP Production
- Troubleshoots and problemsolves to initiateand execute/monitor corrective actions
- Executed process scale and filtration techniques for bioprocessing operations. ( tangential flow, normal flow)
- Accurately reviews batchrecords and other data, ensuring consistency
- Biologics downstream development and manufacturing
- Successful completion of Clinical, Validation, and commercial batches with vaccine product.
Sr.Officer Upstream Processdevelopment
Shantha Biotechnics Ltd
12.2010 - 10.2015
- Performed Technical transferof Uptream processesand Scale-up/scale-down of Uptream processes
- Upstream process design,optimization, and tech transfer to clinical manufacturing
- Assist process tech transfer to GMP manufacturing, on-floor production support and troubleshooting production issues
- Researches and developsexisting and new technologies/process improvements
- Maintains documentation of experiments and/or batch records according to good documentation practices
- Initiates, directs and executes scientific research for innovation and process improvements
- Provided on-going supportfor modification and de-bugging of manufacturing and materialhandler automation equipment, resulting in a major reduction in down time
- Provide project update,analysis and advice to cross-functional team and seniormanagement
- Provided technical expertise on upstream portion of the vaccine production processes within process development and GMP manufacturing.
- Developed and executedprocess validation and cleaning validation document for manufacturing methodsusing GMP.
- Optimization of criticalprocess parameters for achieving the target molecule
- (A SanofiCompany)
Research Executive
Sreeven pharma Pvt Ltd
12.2009 - 12.2010
- Isolation and purification of proteins and phospholipids using column chromatography and ion exchange chromatography accordin g to GMP guidelines
- Analysis of proteins using SDS-PAGE and ptrotein assays, Analysis of phospholipids using TLC(thin layer chromatography) and phospholipid assays.
- Development of methods for isolation and purification of proteins and phospholipids.
- Collection and application of different methods of isolation, to reduce the cost of the product.
Education
Masters in Bio - Technology ( M.Tech ) -
Jawaharlal Nehru Technological University Hyderabad
01-2014
Bachelor in Bio - Technology ( B.Tech ) -
Vinayaka Missions University, AVIT Chennai
Chennai01-2009
Skills
- Scale up
- Technology transfer
- Project quality tracking
- Strategic planning
- Troubleshooting
- Escalated issue resolution
- Testing
- Documentation
- Product procedures development
- Program development
- Lab strategy
- Product validation
- Vaccine development
- Standard operating procedure (SOP)
- CGMP manufacturing
Key Projects
- Pertussis vaccine
- Hemophilus Influenza Type B vaccine (Hib)
- HPV vaccine (Recombinant in E. coli)
- Cholera Vaccine
- Pneumococcal conjugate Vaccine
- Bivalent typhoid Vaccine (Typhoid and Paratyphoid)
- Mastitis Tetravalent Vaccine (For Bovine)
- Fish vaccine
- Clostridium bivalent vaccine (Clostridium Type -C and Type-D)
- Malaria vaccine
- Poultry vaccine
Timeline
Deputy Manager, Upstream Process development
Indian Immunologist Ltd
10.2015 - Current
Sr.Officer Upstream Processdevelopment
Shantha Biotechnics Ltd
12.2010 - 10.2015
Research Executive
Sreeven pharma Pvt Ltd
12.2009 - 12.2010
Masters in Bio - Technology ( M.Tech ) -
Jawaharlal Nehru Technological University Hyderabad
Bachelor in Bio - Technology ( B.Tech ) -
Vinayaka Missions University, AVIT Chennai