COVERING LETTER

Dear Sir/Madam I am a postgraduate in M.Sc. ( Bio -technology) from peruyaruniversity ,,(2005), Andhrapradesh. I have 6 years, industrial experience after post graduation in Biopharmaceuticals industry. Presently I am working as Sr.Executive (production). Responsible for fermentation and down stream operations. I am Presently working for BIOLOGICAL. E. Ltd. ,SP Biotech park, Genome valley,Hyderabad. Which is the manufacturer of, Diphtheria, Pertitus, Tetanus,Hepatitis-B and Hib. having state-of-the-art facility complies with the WHO & US FDA GMP guidelines. I am playing a key role in the pertussis vaccine (Bacterial vaccines)production department. With a balanced experience , I look forward to have an interaction with your good selves to have mutual benefit. Thanks and warm regards.

K.VIJAYASARATHI BABU.

K.VIJAYASARATHIBABU H.No:6-18, Jeedimetla(village), Quthybullapur(mandal) R.R District( AP) -500055. OBJECTIVE

Ph No : +919440925065 E-Mail : vijjibio@gmail.com

Seeking to handle increasing responsibility and challenging assignments to harness my technical skills, knowledge and achieve recognition. I want to be a part of an environment that promotes team effort and value based growth as well as career advancement while making a significant contribution to employer organization. SUMMARY

Having 3 years of experience in Up Stream and Down Stream activities of

bacterial vaccines production (pertussis ) PROFESSIONAL EXPERIENCE
Working as a Sr.Executive from April -2009 to till date in Bacterial vaccines prodution department at BIOLOGICAL E.LIMITED, SP biotech park phase-II,Genome valley, HYDERABAD .having state-of-the-art facility complies with the WHO & US FDA Good Manufacturing practices guidelines, Worked as Chemist (July 2007- April 2009) in BIOMAX (P) LTD at SP Biotech park, Turkapalli, HYDERABAD, Andhra Pradesh. Worked as Production Chemist (July 2006- June 2007) in SENTINI BIOPRODUCTS (P) LTD at Gandepalli village, Vijayawada, Andhra Pradesh. Plant Profile:Dry Milling Grain based 125 KLPD ENA and 30 KLPD Ethanol with Multi pressure Vacuum System through DCS operating.

STRENGTHS Expert in operation of large scale fermentors(70L,1200L & 1800L Capacities) scaling from seed to 1000 L hands on fermentation for bacterial vaccines.(pertussis ) Preparation of cell banks-WCB & MCB and seed revival Production media preparation for batch fermentation process. Aseptic operations & sterilization procedures, Optimisation of operating procedures involved in upstream & down stream process to increase specific productivity following cGMPguidelines. Ensuring complete in-process quality control and continuous improvement in process capabilities. Planning of production process for the manufacturing of pertussis bulk vaccine Handling of air & liquid filteration systems and cellseperation technologies. Preparation of SOPs & Knowledge in current GMP , GLP & good documentation procedures. Actively participated in WHO Audits & GSK Audit

EDUCATION
Master of Science with specialization in the field of Biotechnology from

Periar University in April 2005 and secured First class (68%) Batchelor of Science with Microbiology, Botany and Chemistry as the main

subjects from Sri Venkateswara University, Tirupathi in April 2003 securing First class (67%).

COMPANY PROFILE: Biological E Limited was established over 50 years ago. It was the first Indian private company to enter into the production and marketing of vaccines in the country. With its specific focus on paediatric and adult vaccines(DPT,Hep-B,HIB) with a significant share of the Indian vaccine market. The product Bett from BE is the marketleader in Tetanus Toxoid segment in India. Biological E Limiteds dedicated manufacturing facilities have been awarded with the WHO GMP certification. It Has built up a state-of-the-art Technology project at Biotech Park Phase II Genome Valley - in Andhra Pradesh to produce a new generation of vaccines in order to

reach out to international markets. This project complies strictly with the WHO and US FDA Good Manufacturing Practices guidelines. aimed at acquiring WHO prequalification for all the product JOB RESPONSIBILITIES:

Testing and validation of Fermentor systems produced as per the designed

cGMP protocols for Installation Qualification and Operational Qualifications During Site Acceptance Test (SAT). Preparation of seed cultures & Fermentation. Inprocess quality control tests like microscopy,OD,opacity,sterility ,purity and non viability tests of pertussis bulk antigen. CIPs and SIPs of fermentors and product vessels.. Maintaining the quality standards as per cGMP policies. Preparation of Production Media for the Batch Process. Involved in Up Stream and Down Stream Processing Of Bioproducts. . Preparation and review of SOPs, BPRs. Maintainance of classified aeas according to CGMP Requirements. Harvesting ,Heat inactivation ,& polling of pertussis bulk antigens (strains-509 & 134) Organising of new instruments, its installations & qualifications( IQ,OQ,PQ) Handling of change control & Deviation procedures Participated in failure investigations & its necessary CAPA (Corrective & preventive actions Maintenance of GCRs,Log books,BPRs,SOPs,& change controls

EQUIPMENTS/BIOTECH SYSTEMS HANDLED: Fermentors (make:Sartorius -semi automatic.- 70L & 1200L capacities.) Fermentors (make:Biozeen -fully automatic- 1800L capacity) Westfalia separator (make: GEA) Filter integrity testing systems (make:PALL) CIP& SIP modules(make: Machine fabriwerk) Autoclaves(make:Machine fabriwerk) Laminar airflow units. Shaker incubators Compound microscope Spectrophotometer(UV / Vis) Temperature,pH & conductivity probes caliberation. Centrifuge Cold rooms& deep freezers

ACHIEVEMENT

I led team efforts for maximum fermentation batches with a 100% success rate. Commissioning of the equipments along with the Installation (IQ), Operation (OQ), Performance (PQ) qualification documents required for the Bacterial vaccines.

PERSONAL ATTRIBUTES Committed to success in achieving team and personal goals. Strong work ethics disciplined and self-motivated. Co-operation and Co-ordination with inter related departments

COMPUTER SKILLS MS Office Internet concepts PERSONAL DETAILS Name Date of Birth Sex Nationality Marital status Languages known : : : : : : : K.Vijayasarathibabu 01 - 06 -1982 Male Indian Single English, Telugu. K.VIJAYASARATHIBABU H.NO: 6-18,Jeedimetla(Village), Quthbullapur(Mandal), R.R District-500055.

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