Scientist II - Manufacturing
Thermofisher scientific
Total years of experience :19 years, 0 Months
Role and responsibilities: • Immunogen design, cloning, sequencing, expression in E.Coli and/or mammalian cells, protein purification and analysis
• Handling Lab scale downstream purification process and analytical development for new recombinant oligoclonal and Monoclonal Antibodies.
• Polyclonal antibodies purification by Immuno-affinity chromatography, ELISA analysis and validation.
• Responsible for providing CAPA for the audit observations related to the R & D and QC department.
• Part of the internal audit team and have audited manufacturing department.
• Faced Internal Quality Audits, Global R & D audit team and ISO 9001 audits as a representative of the R & D and QC teams.
Additional responsibilities: • Safety committee team member updation of Compliance documents to EHS manager pertaining to R&D and Manufacturing departments.
• Safety coordinator of the Lab
• Compliance of Legal documents pertaining to the Lab such as consumption of water, waste generation, and use of solvents, readings of noise exposure are documented under the perview of EMS (Environmental Management System)
• Part of the 5S team for the Lab, also part of giving volutary initiatives relating to safety and Environment.
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 update on scientific, clinical and training materials of medical devices for TB, Blood culture- sepsis and Malaria with respect to guidelines and products for end users and Distributors.
• 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.
• 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.
Role and responsibilities: • Cloning, Expression of target genes in Mammalian and E.coli expression systems, purification of recombinant proteins.
• ELISA method development, validation.
• Lab set up for cloning, expression, protein purification, cell culture and train peers.
• Preparation of SOPs, maintenance of lab equipment etc.,
• Maintain to keep Lab note book up to date.
• Initiate new project proposals, interacting with the customers and updating the project status.
Role and responsibilities: • Expression of target constructs in Insect cell lines (Baculovirus) and E.coli expression systems
• Purification of recombinant proteins, analysis, report preparation.
• Involved in Lab set up for cloning, expression, protein purification, Insect cell culture.
• Preparation of SOPs, 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.
❖ Worked as a Research Associate in Discovery Research Team in Research & Development wing at Shantha Biotechnics Limited (www.shanthabiotech.com), Hyderabad.
Role and responsibilities: • New promoter Identification, construction of novel Methylotrophic yeast.
• Generation of polyclonal antibodies for desired proteins.
• Under standing, learning the new techniques in molecular biology, other areas.
• Interacting and 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.
Ph.D in Biotechnology from Nagarjuna University, Guntur, India
❖ M.Phil Biotechnology from Bharthidasan University, Trichy India 2006-2008.
❖ M.Sc Microbiology from Sri Krishnadevaraya University, Ananthapur, India 2002-04.
B.Sc Dairy science from Sri Venkateswara University, Tirupathi, India 1999-2002.