Professional Documents
Culture Documents
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OBJECTIVE
Intend to build career with leading corporate of hi-tech environment with committed and
dedicated people, which will help me to explore myself fully and realize my potential and
willing to work as a key player in a challenging and creative environment.
SYNOPSIS
• A result oriented Professional with 3 years of exposure in Bio-
Technology sector.
• Presently working in Merck Project “15 valant Pneumococcal
conjugate vaccine”.
• Process Development & standardization of upstream and down
stream process for various Biological products like Pertussis, Hib vaccine.
• Having sufficient knowledge in the field of Fermentation technology
and purification techniques.
• Good communication skills, inter-personal relationship skills, with
ability to work in a multi cultural environment.
AREAS OF EXPERTIZE
• Upstream and Down stream process in vaccine development and
production.
• Production planning and execution.
• Execution of documents like URS, FAT and SAT protocols.
• Execution of GMP documents like IQ, OQ & PQ.
• Preparation of SOPs.
AUDITS FACED
• D.C.G of AP GOVT (SECHEDULE-M)
• MERCK audit
WORK EXPERIENCE
• Presently working as an executive in M/S. Biological E Ltd,
Shameerpet, Hyderabad, A.P.
• Above 3 years of experience in the area of biologicales as a
management trainee and executive still date.
Job profile:
1
• Whole cell Pertussis bulk vaccine production which includes
fermentation, centrifugation, heat inactivation and sterility testing.
• Worked in “Pneumococcal Conjugate vaccine” a
polysaccharide vaccine (MERCK project) for Phase1 development in Biological E
Ltd.
• Process Development of Hib vaccine (Haemophillus
Influenzae type B) on both Upstream and down stream process.
• Involved in FAT, SAT executions and IQ, OQ and PQ
executions of all equipments and area qualification for the Phase 3 development
of Pneumococcal Conjugate vaccine production.
• Preparation of SOPs and BPRs.
• Deviations and change controls.
• On job training to new joiners.
• Raising material indents and production consumables.
CULTURES HANDLED:
• Haemophillus Influnzae type B (Hib)
• Bordetella Pertussis
EQUIPMENTS HANDLED
Fermentors:
• 1250 litters (Make: Sartorius)
• 600 litters
Centrifuges:
• Ultra centrifuge 50000 rpm (Make: Beckman)
• Table top centrifuge Eppendorf 25000 rpm (Make: Beckman)
• Alfa Laval centrifuge.
Chromatography Systems:
• HPLC ( make Waters) detectors RI and PDA
Filtration systems:
• Tangential flow filtration systems 0.1 m2 (Make: Millipore).
• Tangential flow filtration systems 0.5 m2, Pellicon system
(make Millipore)
• Micro filtration system 0.5 m2, 0.45 µm (Make: Sartorius)
• Cartridge Filtration Systems size 6 Inches, 10 Inches, 20 Inches
• Pilot scale Tangential flow filtration system 2.5m2.
Homogenizer:
• Niro Soavi table top Homogenizer (Make: GEA)
• Niro Soavi manufacturing scale Homogenizer (Make: GEA)
2
Integrity checking machine:
• Millipore integrity test4 (make Millipore)
Analytical equipment
• Conductivity Meter: Orion 3star (Thermo Electron Corporation)
• pH Meter: Orion 3star (Thermo Electron Corporation ) and Accumet AB15
(make Fisher Scientific)
Documentation:
• Standard Operating procedures (SOP’s, LCR, BPR)
• Preparation of production planning including Shift Schedules.
• Involved in SAT and FAT of equipments and involved in IQ, OQ and PQ.
Seminars attended:
• Blood clotting factor seminar held on 20th August, 2005 at Sri Ramchandra
University, Chennai.
• Human Genomics international seminar held in between 25th to 29th January 2007
at Sri Ramchandra University, Chennai.
• Attended for the FDA 21 CFR part 11 compliance in practice and computer
system validation on 7th August 2009.
Achievements:
3
• Awarded with “Award of Excellence” for outstanding dedication and operation
support of Pneumococcal Conjugate vaccine Suite Qualification from Merck
MSD.
ACADEMIC QUALIFICATION
• Completed M.Sc., in the year 2007 (Biotechnology) from Sri Ramchandra
University (UGC act 1954), Chennai, Tamil Nadu.
• Completed B.Sc in the year 2005 (Bio Technology, Bio Chemistry and Zoology)
from RITAMS degree college, Tanuku affiliated to Andhra University.
Reference
P. Venugopal Rao,
Asst General Manager,
Recombinant Vaccines,
Biololgical E Ltd,
Hyderabad, Andhra Pradesh,
Ph NO: - 09704456031
Personal
M. Swamy Ayyappa.