Manager, Quality Control Experience

CURRICULUM VITAE

Pachaiyappan Viswanathan

Permanent Address

No. 301, Priyadharshini Appartments No.

**/**, *********** ******

Ananth Nagar

Vedachala nagar

Manipal

Kancheepuram.

Udupi

Tamil Nadu

Karnataka

Pin code - 576104

Pin code - 631501

Cell: +91-819*******

Cell : +91-989*******

E-mail: *******@*****.***

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SUMMARY:

Stem cell researcher cum Flow Cytometry Lab manager

. 6.8 years of experience in biotechnology industry with

specialization in flowctometry, stem cells research, manufacturing and

clinical trial.

. Expertise in validation, experimental design, acquiring and presenting

high quality flow cytometry data, and high speed cell sorting usins BD

FACS Aria.

. Highly proficient in data analysis using CELL QUEST, CXP, FACS

Diva, FLOW JO and GUAVA Cytosoft software platforms.

. In depth knowledge of a wide range of multi-color flow cytometry

assays and applications.

. First prize winner in the 12th Indo US flowcytometry workshop held in

MLSC, Manipal received the "Avtar Krishnan award".

. Trained more than 100 students on flowcytometer basics.

. Experienced in large manufacturing of allogeneic bone marrow derived

MSC's in GMP facility for clinical trials for CLI, osteo arthritis, Liver

cirrhosis and diabetes.

. Experienced in processing of autologous bone marrow derived MSC's and

HSC's in GMP facility for clinical trials for Spinal cord injury, Liver

cirrhosis, cerebral palsy and diabetes.

. Part time tutor in Loyola college for 1.5 years on stem cells and

regenerative therapy.

. Worked both on hematopoeitic, mesenchymal stem cells and side

population cells in cord blood, Adipose tissue and bone marrow.

. Expertise in stem cell culture, large scale expansion and

differentiation assay.

. 2 years experience in both autologous and allogenic clinical trial

using stem cells.

. Broad understanding of biotechnology industry from research

perspective.

. Excellent technique working with applications requiring sterile

conditions.

. Experience working with bio-hazardous materials.

. Strong background in immunology and associated assays.

. Personable, organized, and efficient employee who takes pride in

his work.

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EDUCATION:

Master of Science in Applied Micro Biology

Kanchi Sri Krishna College of Arts and Science affiliated to

University of Madras, India.

Date of graduation: April 2003.

Bachelor of Science in General Micro Biology

Minor in Bio physics and Bio-chemistry

Sri Sankara Arts & Science College affiliated to University of

Madras, India.

Date of graduation: April 2000.

RELATED SKILLS:

Diploma in Computer Science and Applications - June to November 1998,

Global Advanced Software College, Kanchipuram, India.

Computer Skill:

Operating System: MSDOS, Microsoft Windows XP, Windows NT and MAC.

Programming Language: C, FOXPRO

General: Microsoft Word, Microsoft Excel and Microsoft power point.

Languages Known:

Fluent in English and Tamil

Intermediate in Hindi, telugu and kanada

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PROFESSIONAL EXPERIENCE:

Senior executive quality control

Jun 2011 - till date

Stempeutics research PVT LTD.

Manipal, Udupi, karnataka, India.

. Immuno Phenotyphing of MSC's using GUAVA EASYCYTE PLUS and BD LSR

II flowcytometer.

. Large scale expansion of bone marrow MSC's for clinical trials trials for

CLI, osteo arthritis, Liver cirrhosis and diabetes.

. QC testing of the raw materials for release to production

. Environmental monitoring of clean room area

. Bacterial Endotoxin Test (BET) of samples

. Mycoplasma detection by PCR ELISA method

. . Osmolality test of samples by Precision systems OSMETTE.

. Cell count by ViCELLXR cell viability analyzer from Beckmann coulter.

. Culturing and expansion of MSC's.

. Invivo Differentiation assay of MSC's into adipocytes, osteocytes and

chondrocytes

. BSA estimation by ELISA method

. Trypsin assay by ELISA method

. VEGF assay by ELISA method

. Cold chain management studies.

. Stability studies

. Method validations and e quipment validation.

. Performance qualification of equipments.

. Preparation of SOP's, STP's and AWS's.

. CAPA and root cause analysis.

. Certified Internal auditor for 9001:2008

Product Manager-Lab manager

August 2010 - March 2011

Lifecell International PVT LTD. - Cord Blood Bank

Keelakottaiyur, Chennai, India.

. Managed whole cord blood processing unit, Quality control unit

and documentation team.

. Monitored and organized the efficient processing of cord blood.

. Monitored quality control analysis of cord blood and cord tissue

samples.

. Performed short term and long term stability test of

cryopreserved cord blood samples.

. Prepared cryo protectant DMSO in house which is used for cryo

preservation of cord blood samples.

. Carried out the both forward and reverse bag processing of cord

blood.

. Prepared protocols for process validation, reagent validation and

material validation.

. Expertised in flow cytometry (BD FACS Caibur) in experimental

design and troubleshooting.

. Monitoring on time generation and dispatch of client reports.

. ?raining people before getting involved in process.

. Preparing SOP's and trend charts.

. Created and maintained a detailed inventory of all materials and

reagents for the entire unit.

. Performed internal Lab audits, experienced as auditee and auditor

. Faced Audits like College of American Pathologist (CAP),

International Organization for Standardization (ISO) and National

Accreditation Board for Testing and Collaboration Laboratories (NABL).

Junior RESEARCHER - Adipose and Bone marrow derived stem cells processor

and Flow Cytometry Operator

January 2008 - April 2010.

Rigid healthcare PVT LTD., A unit of Lifeline multispeciality hospitals,

Perungudi, Chennai, India.

. Helped in setting up of the stem cell laboratory in the facility.

. Planned and executed complex multi-color flow cytometric

immunophenotyping experiments.

. Analyzed large quantity of flow cytometry data using BD FACSDiva

software platform before presenting to principal investigators.

. Consulted with principal investigators and post-doctoral scientists

regarding optimal gating strategy for sorting of precious rare

subpopulations under sterile conditions.

. Sorted rare subpopulations of cells under sterile conditions for

subsequent cell culture assays in BD FACS aria cell sorter.

. Utilized magnetic separation for pre-sort enrichment of adipose

derived stem cells and bone marrow derived stem cells.

. Responsible for daily calibration, maintenance, and operation of

a two laser BD FACSAria cell sorter.

. Trained scientists, technicians and students in basic

immunostaining, operation of a BD FAC Aria cell sorter, data acquisition,

and data analysis.

. Created and maintained a detailed inventory of all flow cytometry

reagents.

. Organized and archived all flow cytometry data electronically,

and maintained daily quality control records.

. Planned and performed large scale multi-color experiments for flow

cytometric analysis.

. Studied, analyzed and organized large data sets before presenting to

senior scientists and principal investigator.

. Processing of mobilized peripheral blood, cord blood, bone marrow

aspirate, subcutaneous fat, thymic fat, omentum fat, buccal mucosal

tissue for the isolation of stem cells to be used for clinical trials.

. Characterization of haematopoeitic stem cells, mesenchymal stem cells,

side population cells and ALDH bright cells etc.,

. Cell sorting by MACS (Magnetic-Activated Cell Sorting)-Miltenyi biotec

. Application of stem cell in regenerative medicine clinical trial for

spinal cord injury, motor neuron diseases, neuro degenerative diseases,

liver cirrhosis, diabetes etc.,

. Preparing SOPs, validations of new equipments and standardization of

new protocols

. Lectured for 2 months to students joined for summer training course

jointly conducted by LOYOLA College and LIFELINE hospital

. Delivered guest lecture to students in JAYA Arts and Science college,

Chennai, India on Stem cells and its clinical applications

. Guided more than 50 P.G. students in their academic project works

based on stem cells.

. Trained national and international students in Flow cytometry

operation and applications.

. Worked 1.5 year as tutor for students of P.G. Diploma in stem cell

therapeutics course conducted by LOYOLA College and LIFELINE hospital

. Active team member in going through DSIR and SIBRI inspections

Junior LAB TECHNICIAN - Quality control Unit January 2006 -

December 2007

Lifecell International PVT LTD. - Cord Blood Bank

Keelakottaiyur, Chennai, India.

. Performed daily set-up and operation of BD FACS Calibur and BC FC

500 flow cytometers.

. Performed daily set-up and operation of SYSMEX XT 1800i and Sysmex

pochi 3 part hematological analysers.

. Responsible for daily maintenance and calibration of BD FACS

Calibur and BC FC 500 flow cytometers.

. Provided technical expertise for research staff in the operation

of the FACS analyzers and use of associated software.

. Analysed cord blood samples for stem cells using BD FACS caliber and

Beckman coulter FC 500 flowcytometers

. Carrying out blood grouping and Rh typing by tube method

. Processing of cord blood samples by density gradient centrifugation

using LSM and Hepes

. Cryo freezed processed cord blood samples

. Analysed maternal blood sample for any infection diseases by ELISA -

EVOLIS instrument

. Preparing SOPs and purchase orders and validations of new equipments

and protocols

. Performed internal Lab audits, experience both as auditee and

auditor.

. Active team member in going through ISO, Drug control inspection and

American Association of Blood Banks accreditations

. Organized and archived all flow cytometry data electronically,

and maintained quality control records.

HANDS ON EXPERIENCE:

. BD FACS Aria cell sorter flowcytometer with DIVA software

. BD FACS Calibur flowcytometer with CELL QUEST software

. Beckmen coulter cytomics FC 500 flowcytometer with CXP software

. GUAVA EASYCYTE PLUS flowcytometry with GUAVA Cytosoft software.

. BD LSR II flowcytometry with FACSDIVA software

. Pure culture isolation, staining and identification of microbes

. Processing of cord blood or bone marrow aspirate samples -

Density gradient centrifugation

. Adipose derived Stem cell isolation, characterization and

culture

. Isolation of stem cells from cord tissue and Wharton jelly of

cord.

. Large scale expansion of Mesenchymal stem cells

. Magnetic bead sorting Miltenyi Biotech setup

. Quality control procedures

. Adult Stem cell culture techniques

. Cryo preservation of cells

. ViCELLXR automated cell viability analyzer

. Sysmex XT 1800i - automated hematological analyzer

. Sysmex pocH 100i - automated hematological analyzer

. Bactec 9050 microbiological cabinet

. Bactec 9120 microbiological cabinet

. ELISA reader BIORAD

. Evolis fully automated ELISA equipment

. OSMETTE by precision systems

. CFU-f assay

. Differentiation assay

. Environmental Monitoring of clean room environment

. Aseptic procedures

. DNA isolation/RNA isolation/Plasmid isolation

. SDS-PAGE

. Western blotting

GOOD KNOWLEDGE IN:

. Flowcytometry

. Immunology

. Stem cell biology

. Developmental biology

. Cell biology

. Microbiology

PUBLICATIONS

. Co author of research paper "Characterization of Human Adipose

Tissue derived Hematopoietic Stem Cell, Mesenchymal Stem Cell and Side

Population Cells" published in International journal of biology,

January 2010 edition, Vol.2, No.1.

PRESENTATIONS:

. Presented poster in International Stem cell Summit - November 2007,

topic - Effect of serum on the viability of various stem cell

populations isolated from human bone marrow: Optimization for autologous

transplants.

SEMINARS ATTENDED:

. Attended a 2 day State level seminar on recent trends in microbial

biotechnology at Sri Sankara Arts & Science College, Kanchipuram,

India.

. Attended 3 day - International Stem cell Summit on November 2007

at IIT Madras, Chennai, India.

. Attended 1 day Stem cell Global Symposium (SCGS-2009) on November

2009 at MRIU campus, Faridabad, Haryana, India

Awards:

. First prize winner in the 12th Indo US flowcytometry workshop held in

MLSC, Manipal conducted by Miller institute of medical sciences and

MLSC. Got the "Avtar Krishnan prize award".

PERSONAL DATA:

Place of Birth : Kancheepuram, Tamilnadu, India

Nationality : Indian

Marital Status : Single Male

Date of birth : 31/10/1979

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REFERENCES:

. Dr. Preeti Kapoor, Ph.D.,

Group Leader and Senior Scientist

CMBRC, AHERF,

Apollo Hospitals,

Jubilee Hills,

Hyderabad,

Email: **************@*******.***

Cell: +91-40-889-***-****

. Dr. Aasawari Bapat

Quality Assurance Director

Questar Enterprises,

402, Al Muhaisnah Plaza,

Beirut Street, Al Qusais,

PO Box:6824

Dubai UAE.

Pnone :+971-*********

Email: *************@*****.**.**

. Mr. Ramesh M

Quality Manager

Singapore Cord Blood Bank

Phone: +65 83549522

Email: *********@*****.***

. Mr. Ashwin K. M

QC Incharge

Stempeutics Research private limited

4th floor, Shridi Sai baba cancer hospital,

Manipal, Karnataka

Cell: +919*********

Email: **********@*****.*** [pic]

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