• Handled various R&D, Contract research and Manufacturing projects from different clients with regards to protein purification and characterization. • Consistently apply innovative and advanced technical skills to provide support to process development, technology development and manufacturing services. • Adept in handling audits, imparting training, developing & implementing process. • Excellent management skills, strong analytical, problem solving & organizational abilities. • Excellent knowledge with computers both basic and advanced. Well versed with MS Office (MS Word, MS Excel, MS Power Point) Lotus wordPro and Internet applications. • Knowledged in usage of Invitrogen VectorNTI Software, BIOEDIT, Sequencher, Graphpad prism, Enterprise one (E1) for materials procuring and Manufacturing related activities, Agile for product life cycle management, Trackwise for CAPA activities etc.
CLINICAL RESOURCE CONSULTANT
Since June 2016
Built and maintain productive relationships with the Sales/Application and marketing teams by: • Conduct, Organize and participate in Scientific Meetings and Medical Conferences. • Develop and maintain solid business relationships with strategic partners and KOL’s in the Clinical Laboratory Market, Safety leaders. • Develop and implement the Clinical Development Plan for the business by Adapting and developing concepts around the product positioning. Planning product strategies and Interpret research findings and make recommendations of its use to the sales and marketing team/s. • Develop and update on scientific, clinical and training materials of medical devices Blood culture, ID/AST, RT PCR, MALDI, Lab automation and products for end users and Distributors. • Create a relationship network with KOL’s, Customers and Experts in order to facilitate registration, approvals, positioning and promotion of products. • Work closely with and develop relationships with Professional Organizations overseeing and related to the business. • Organize and coordinate training for new and existing customers, Distributors and Distributor employee’s in collaboration with the respective Product Manager. • Organize and coordinate post-marketing clinical research in the Country.
June 2011 --- June 2016
• Planning and executing upstream process mammalian cell culture processes HEK-293, optimization, trouble shooting for new recombinant oligoclonal and Monoclonal primary and secondary Antibodies. • Design of expression constructs and expression in mammalian cell lines. • Handled Immunogen design, cloning, bacterial expression and protein purification for generating recombinant monoclonal and oligoclonal antibodies. • Handled protein purification of recombinant oligoclonal and monoclonal primary and secondary antibodies. • Handled Polyclonal antibodies (Goat Anti Rabbit, Goat Anti Mouse, Goat Anti Human etc) purification by Immuno-affinity chromatography, ELISA analysis and validations. • Responsible for review of Manufacturing SOP, Batch records, CAPA for process and for the audit observations related to the manufacturing department. • Training new personnel in the lab on various technical cellular and molecular biology techniques and non-technical such as maintain lab inventory, equipment, processes.
March 2010 --- May 2011
• Cloning, Expression of target genes in Mammalian and E.coli expression systems, purification of recombinant proteins for diagnostic, drug discovery projects. • ELISA method development, validation. • Lab set up for cloning, expression, protein purification, cell culture. • Preparation of SOPs, responsible for IQ,OQ,PQ and maintenance of cloning, cell culture, protein purification lab equipments etc., • Train colleagues and help, guide Ph.D students for cell culture related related activities (part of their thesis work).
December 2007 --- May 2010
• Expression MOI optimizations for target constructs in Insect cell lines such as Sf9,Sf21, Hi5 etc (Baculovirus) and E.coli expression systems • Purification of variety of recombinant proteins from bacteria and insect cells, analysis, report preparation recombinant proteins for drug discovery projects. • Team member for Lab set up for cloning, expression, protein purification, Insect cell culture. • Preparation of SOPs, Documents, maintenance of lab equipment etc., • Interacting with the client and updating the project status, technical seminars etc. • Training subordinates, colleagues in protein chromatography, protein purification, Insect cell culture.
January 2004 --- November 2007
• New promoter Identification, construction of novel Methylotrophic yeast. • Generation of polyclonal antibodies for desired proteins concentration by TFF systems. • Under standing, learning the new techniques in molecular biology, other areas. • Interacting Closely working with the other group members for troubleshooting experiments. • Growth curves of bacteria, methylotrophic yeast and WCB, MCB preparations. • Troubleshooting experiments on behalf of production team, Pivot member in technology transfer.
Analytical thinkingAssertivenessCompetitivenessCritical thinkingCreative thinkingFlexibilityInnovative thinkingOptimismOrganization
Skills and Expertise
Analytical skills Analyze data Create SOPs Molecular DiagnosticsAnalyze proteinAseptic techniquesCell cultureCoordinate ethics committeeCoordinate logisticsDesign scientific projects (in biology)Use laboratory techniquesUse western blotting techniqueValidate dataVerify dataWork collaboratively with the other members of the clinical research team Work cross-functionallyWork under specific instructionsWork with coordination and data management teamsWrite documents
Doctor of Philosophy (Ph.D.) in Biotechnology from Acharya Nagarjuna University in 2015
M.Phil in Biotechnology from Bharathidasan University in 2008
M.Sc in Microbiology from Sri Krishnadevaraya University in 2004
Bachelor’s Degree in Dairy Science, Zoology, Chemistry from Jawahar Bharathi degree college in 2002
Training and Certification
Manufacturing Academy Certification
Project Management Academy Certification
Quality, Regulatory and EHS Academy Certification