Quality Assurance Process

N. PALANI

Mobile: +91-839*******

E-Mail: ************@*****.**.**

In pursuit of career enhancing opportunities in the field of:

~ Research & Development ~ Production Management ~

SYNOPSIS

Offering over 5 years of experience in Research & Development and Production Management.

Adept at development and validation of analytical and bio-analytical methods. Possess thorough knowledge of Fermentation & down stream process.

Skilled in conceptualizing and evaluating ideas, making them tangible through new product development in a more systematic approach.

Expertise in product designing as well as interacting with fatigue lab, field-testing department as well as actual end customers.

Research experience includes outstanding ability to analyze, gather, write, evaluate and produce detailed reports on a variety of projects

Ensuring compliance to quality measures and maintenance of appropriate requisite documentation as well as records.

Proficient in maintenance, calibration and troubleshooting of analytical equipment, thereby enhancing productivity. Ensured compliance of various quality measures by maintenance of appropriate requisite documentation/ records.

Career Graph

Feb’08-Feb’11 Alkaloids Corporation, Kolkata, One of the Unit Deccan Nutraceticals Pvt Ltd, Pune as Project Consultant

May’07-Jun’07 INDFRAG Ltd., location as Scientific Officer (Process development)

Jun’05-May’07 Alchem International Ltd., location as R&D Microbiologist

Core Competencies

Research & Development

Identifying, collecting, processing, analysing and cataloguing data/ samples according to established protocol, procedures & standards, as appropriate to specific objectives of the research study; planning and organising day-to-day research activities and resolving procedural problems as appropriate to the timely completion of research objectives.

Setting up, calibrating, operating and maintaining a variety of laboratory and/or field research equipment as specified by the requirements of the research study.

Coordinating production of Co enzyme Q10 from certain GMO soil bacteria; establishing biotechnology laboratory at company premises; technology improvisation and validation for protective thiocolchicine (TC) to Demethyl thiocolchicine (DMTC) using rec – B.megaterium.

New Product Development

Suggesting new ideas; preparing project plans and technical specifications for smooth execution of projects within the time and cost parameters.

Overseeing the preparation of designs, design verification & evaluation, engineering & production trials.

Generating new ideas, carrying out product design, and detail engineering; overseeing market research and marketing analysis related to the same.

Quality Assurance & Testing

Reviewing technical specifications, stability / validation protocols, reports & other quality documents.

Ensuring compliance with all the quality standards for analytical trials in coordination with unit QC labs, product development division, Scientific Departments.

Maintaining quality standards for incoming materials, ensuring stringent adherence to quality standards, norms & practices, identifying gaps and taking corrective action and Preventive action.

Production Planning

Identifying production targets and achieving the same within time and cost parameters.

Optimising man & machine utilisation to achieve pre set production targets.

Streamlining new process concepts for production optimization, yield improvement and adopting cost reduction techniques.

Highlights

Successfully achieved 75% of conversion yield of the substrate Research is in progress for achieving a higher yield.

Optimised production media and bioprocess parameters for successful scale up from bench scale to commercial production isolation of a potent strain of B. Magaterium, B.Flavus.

Implemented cGMP and Biosafety measures with respect to GMO’s

Developed Colchicines to demethyl colchicines by biotransformation with help of bacillus magaterium, Colchicines to thiocolchicine by synthetic reaction, Thicolchicines to 3-demethyl thiocolchicines by biotransformation with the help of bacillus megaterium and Demethyl thiocolchicine to thiocolchicoside by semi synthetic reaction.

Major Projects

Strain selection for study of phenotypic and Genotypic characterization of bacillus megaterium for strain screening, Mutation study either UV or chemical mutagens, Gene of interest, systems Biology, Enzyme production analysis by genewise,Gene Mapping, vector selection, analysis of DNA(Host DNA Polymerase),RNA(Host RNA Polymerase, Promoter activity,mRNA (mRNA stability),tRNA, rRNA, Protein(Host ribosome’s, SD sequences, Codon usage) production at AT,GC content at %levels,Recombinent DNA Technology, All Molecular Biology Techniques, bioinformatics for sequencing,banding,FASTA,BLASTA.

Preparation of C-13 hydroxyl-bearing taxanes using nocardioides or a hydrolase isolated stherefrom

Production of 3-demethyl colchicines from colchicines by biotransformation with the help of bacillus magaterium.

Production of thiocolchicine from colchicines by synthetic reaction.

Production of thiocolchicine to 3-demethylthio colchicines by biotransformation with the help of bacillus magaterium.

Downstream process extraction and purification and crystallization of 3-demethyl colchicines and 3-demethyl thiocolchicine from the fermented broth

Production of thiocolchicoside from 3-demethyl colchicines and 3-demethyl thiocolchicines by semi synthetic reaction.

Arranging the method of analysis for colchicines, thiocolchicine,3-demethylcolchicine and 3-demethyl thioicolchicine by HPLC and TLC

Biotechnology lab set upping for laminar flow (0.2micron) room with the UV sterilization, airlock systems for interlocking, media storage room, culture room, media preparation room, bioreactor room, biocontroller room for PLC and SCADA automation systems, instrumentation room for HPLC,cold room for culture maintanance.all rooms are 0.2 micron HEPA filter system with the help of AHU(15micron<10micron<5micron<2micron<0.5micron<0.2micron).

Bioprocess plant setuping (bacterial fermentation) for seed fermentor, pilot scale plant production, process maintained, troubleshooting, yield analysis and harvesting.

Utilities for boiler, cooling towers, chilling plant, compressor.

3-demethyl colchicines, thiocolchicine, 3-demethyl thiocolchicine, thiocolchicoside as per cGMP, IP, BP, USP.

Major Project

Production of Demethyl Thiocolchicine from Thiocolchicine from genetically modified (GMO) B. Megaterium

Handled the charging, sterilization, cooling and inoculation process maintenance in 5L, 70L and 150L, 3.5KL, 5.3KL and 20KL bioreactors. (Fermentor make: Applikon dependable instruments, Holland).

Managed the cell separation with disc centrifuge, cell disruption with KD – 20 bid mill, acid precipitation and precipitation separated by tubular centrifuge, sample analysis (Broth, concentrated syrup) using HPLC.

Optimised product formation in shake flask, 3 liter fermenter using bacterial culture; analysed the product by HPLC and spectrophotometer method, Worked on scaling up from 2 liter to 20 liters validation of the process and down stream process.

Screening of high yielding strains using conventional mutation; conversant with systems of literature collection and data processing; functioning as Shift -in-charge of the plant for the production of Bacillus megaterium based THIOCOLCHICOSIDE.

Production (Upstream & Downstream Process)

Handled the following activities:

o Preinoculum development for the batch process from working stock to flask.

o Sterilisation and operation of seed and fermenter

o Monitoring the process (pH, DO, Temp), carbon source and check for contaminants

o Harvesting the products by continuous flow centrifugation, Micro filtration & formulation of the technical.

Scholastics

2005 M.Sc. (Biomedical Genetics) from Vellore Institute Technology, Vellore. Secured 6.5 CGPA.

2002 B.Sc. (Biochemistry) from University of Madras

Academic Project

Epidemiologic and phenotypic characterization of Extended Spectrum of Beta Lactamase (ESBL) producing Klebsiella spp., E.coli &Enterobaecter spp., isolated from hospital wastewater effluent treatment plant.

Organisation : Christian Medical College & Hospital, Vellore

Supervisor : Dr.Dilip mathai, MD, Head of the Department of General Medicine - Unit I & Infectious Diseases

Duration : 6 months

Conferences Attended

XXIX Conference of Indian Society of Human Genetics (29th ISHG 2004) Golden Jubilee Year NIMHANS (Deemed University) (1954-2004) Date: 8th -11th January 2004, Bangalore. Theme: Trends in Human Genetics, Biotechnology & Bioinformatics next 5 years.

International conference on Human Genomic Update, Ameerpet. (Osmania University, Hyderabad); Theme: Human Genomic Update.

Intellectual Property Rights, Vellore Institute of Technology, Vellore; Theme: Intellectual Property Rights, & Ethics.

Personal Dossier

Date of Birth : 2nd April, 1981

Address : Flot No.13, 2nd floor, Thirupathy residency, Dhanoori road, Bhairav nagar, Visranthwadi, Pune-411015

References:

Mr.A.K.Gurtu

Head of the Department

Biotech Lab

Alchem International Ltd

25/2 Madura road

Ballabgarh

Haryana-121004

Dr.Dilip mathai, MD, PhD

Head of the Department

Department of General Medicine - Unit I & Infectious Diseases

Christian Medical College & Hospital,

Vellore

Dr.Mahalingam PhD

Department of Genetics

VIT University

Vellore

Mr.R.Ramesh

Assistant Manager

Life cell International ltd

Chennai.

Mobile: 989-***-****

Contact this candidate