Biomarker discovery,Molecular Diagnostics, Genomics and Regulatory

Narinder Singh

A-***, Gulmohar Garden,

Mallapur,SuryaNagar

Hyderabad, 500096, INDIA

Ph:- +919*********

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

*******@*******.***

Summary

Narinder Singh is PhD Biotechnology and worked as Associate in Bioinformatics, having approx 5.7 yrs corporate experience. His core expertise lies in Project Management (Planning, Scheduling, Monitoring & control, Costing, Resource Management, Reporting and Closing, R & D-Biomarker Discovery, Molecular Diagnostics & Genomics ),Quality Management (Quality Planning, Quality Assurance, Quality Control, Regulatory Affairs, Technology development and validation), Commercial Affairs (Technical Specifications, Tendering / Billing, Liaison Work, Market Research, New Market Development, Technology Transfer) and SAP implementation in Molecular Biology/Biotechnology. Extensive experience in design, optimization, validation and commercial launch of Molecular Biology-PCR based Diagnostic Assays for a broad range of infectious diseases, food and water borne diseases for the Clinical Diagnostics market and molecular biology kits for RUO markets .Leadership experience building a new lab from ground up and developing and supervising laboratory technicians, post-docs, interns, in addition to training visiting scientists• Implementation of scale-up protocols for GMP manufacturing of molecular biology kits. Combination of industry experience and academic research with experience in commercialization process, ability to manage projects independently and achieve results.

Narinder has worked extensively on biomarker discovery(identification and validation of bio-marker for drugs discovery using comprehensive genomic reference databases), Biotechnology diagnostic software (implemented SAP-AGMORIS) and innovation of protocol and products for H1N1 testing, Infectious Disease Molecular Diagnostics, Clinical Molecular Diagnostics, GMO (Genetically modified organisms) testing, Molecular Food safety (PCR based food pathogen DNA tests), Genomics, Genotyping, Sequencing, Molecular Markers in plants, Plant Tissue Culture, Plant Genetic Engineering, Plant ,human and bacterial genomics ,bacterial characterization and identification, and development of various molecular biology kits. He is expert in operating multiple scientific instruments such as ABI Prism 3700 DNA analyzer, MegaBACE sequencer and Mermade oligo synthesizer, PCR (Perkin Elmer, MJ research), Mass Array Compact (Sequenom/Bruker), Nano dispenser (Samsung), Real Time PCR, BD FACS Calibure and Affy Microarray. He has worked extensively on software such as NCBI BLAST, Rasmol, Swiss Pdb viewer, Clustal X, Gene scan, Clustal W, NCBI Comparative modeling, Gene Structure, Annotation, Multiple sequence analysis, Pubmedline, CD-ROM search, NTYSIS-pc, RealSNP (Assay design software from Sequenom), Chromas (a program to view and edit chromatogram files).

He’s an expert in IPR and Regulatory Affairs, with a detailed oriented experience on ISO-17025, ISO 15189:2007, ISO 13485 and ISO 9001:2008 and CE marking accreditations. Conformity to ISO specification on molecular clinical diagnostics and GMO tests (Genetic ID and ISO specifications), ISO standards 17025, 15189, 9001:2008. Broad knowledge of quality control, quality assurance, preparation of SOPs, design and implementation of clinical/biological assays, cGMP & GLP compliance .He worked as Technical manager for Disease Diagnostics, GMO, molecular food testing and basmati authentication, Quality Manager for ISO-17025 and Certified Internal Auditor-ISO-17025, ISO 15189, 9001:2008. He is well versed with FDA regulations, ICH guidelines, EU regulations and has done liaisoning with regulatory agencies as CSDO in the area of molecular diagnostic, FDA, EU, AFNOR Centre for Disease Control, Clinical Laboratory Standard Institute and nodal agencies like Export Inspection Council, BIS,APEDA, NIN, NABL and ICMR. He has been selected for special "Observer" role by "Clinical and Laboratory Standards Institute" , USA for the sub-committee on "Quality Systems and Laboratory Practices"

He possesses exemplary Strategic and planning skills and is an excellent Team Leader, Motivator, Team player.

His Main Interest Areas are Innovation (biomarker discovery, next generation sequencing, Molecular diagnostics, Genomics, Research Informatics) , Drug discovery & Designing and Leadership.

Achievements

Nominated for Biotechnology for Food & Agriculture sectional committee, FAD 23(ISO committee in GMO detection) in 2010.

Selected for special "Observer" role by "Clinical and Laboratory Standards Institute" , USA for the sub-committee on "Quality Systems and Laboratory Practices" in 2009

Received appreciation for the best performance at Avesthagen Ltd-2008

Appreciation from the Chairman & the COO, Avesthagen for successfully facing ISO 17025:2005 audit 2006-2007

Qualified NET (National Eligibility Test ) for recruitment of Assistant Professor in biotechnology- Conducted by Indian Council of Agriculture Research (ICAR), New Delhi-2001

Selected for SRF (senior Research fellowship ) in biotechnology conducted by ICAR, New Delhi-2001

Nominated for Commonwealth scholarship Plan -UK-2003 in Molecular biology (Bioinformatics) by Ministry of Human Resources Development Govt. of India

Selected for six months studentship in Bioinformatics ,sponsored by DBT, GOI, HP University, Shimla

Selected for M.S .Biotechnology on All India competition by Dr. YS Parmar University of Horticulture and Forestry, Nauni-Solan HP-1998

Selected for B.Sc. Forestry on All India competition by ICAR, New Delhi-1994

Professional Summary

Period Organization & Designation

January 2009 – Present BioServe Biotechnologies (India) Pvt Ltd (Hyd)- US MNC, HQ in Beltsville, MD

Group Head- Molecular Testing.

August 2005 –December, 08 Avesthagen Ltd, Bangalore-India- Functional Head – Genomics and Analytical Biotechnology Services

Academics

Degree Institutions Year of Passing GPA

PhD Biotechnology Central Potato Research Institute, Shimla 2006 7.1 (Merit Scholarship)

Master of Science in Biotechnology (Professional) Dr Y S Parmar University, Solan HP 2001 7.0 (Merit Scholarship)

Bachelor of Science in Bio-Resource (4 years professional degree) Dr Y S Parmar University, Solan HP 1998 6.5

OTHER QUALIFICATIONS-PROFESSIONAL ENHANCEMENT

Course Institutions

Qualified Internal Auditor for Quality Management System in Biotech R and D Lab ISO9001:2008 DNV, Hyderabad,India

CE Marking for In-Vitro Diagnostics DNV, Hyderabad,India

Qualified Internal Auditor for Laboratory Management System ISO 17025:2005(Biological) CETE (as per NABL), Bangalore, India

Qualified Internal Auditor for Laboratory Management System ISO 15189:2007(Medical Labs) NITS, BIS,New Delhi,India

PROFESSIONAL EXPERIENCE (~ 5 years)

1. Organization:- BioServe Biotechnologies(India)Pvt Ltd, Hyderabad

Designation:- Group Head/Project Manager-Molecular Testing

BioServe Biotechnologies(India) Pvt Ltd, Hyderabad, HQ, Maryland ,US

Team Size:- 30

Roles & Responsibilities:-

Project Management/ Global Communications

• Proven as a ‘Leader’ by setting a new vision for the work groups and spearhead in that new direction. Establish confidence between the work groups for successful completion of project.

• Responsible for overall in-charge -Supervise and conduct R&D projects in molecular diagnostics(normal and RT-PCR) in HIV,HCV,HPV,TB,H1N1 etc molecular food diagnostics(PCR based detection of food pathogens),GMO detection, molecular biology kits development (RUO and regulated markets),Genomics and CRO services at BioServe, Hyderabad.

• Work with BioServe US on cross-border R & D projects involving bio-marker discovery with global potential such as inflammatory disorders, endocrine disorders, cardiovascular disease, hypertension, obesity, Coronary Artery Disease, Colon Cancer, Lung Cancer, Breast Cancer, Osteoporosis, Osteoarthritis, Obesity, Asthma, Type II Diabetes Rheumatoid Arthritis.

• To perform and supervise molecular diagnostics( normal and RT-PCR) operation for various hospitals and other clients (molecular testing) of infectious diseases, chronic diseases, pre-natal testing and other esoteric tests such as HIV,HBV,HPV,HCV,TB,CD4/CD8,Leukemia(flowcytometery),PML/RARA, BRAC 1 and BRAC2 , Y deletion, JAC 2,CYP2C ,BCR/ABL, Mycoplasma hominis, Treponema, Chamydia pneumonia, Neissera ginirrhoeae,Swinw flu(H1N1) swine flu –CDC protocol (EP and Real time PCR) and to get NABL accreditation ISO 15189:2007 for MDx

• Translating R&D into products and services after validation and testing & thereafter commercializing these after obtaining regulatory approvals

• Responsible for launching ‘molecular testing ’ services and molecular biology kits into global markets after due regulatory approvals such as ISO 17025:200, ISO 15189( molecular testing) and CE marking and FDA510k for molecular biology kits for RUO markets respectively.

• Responsible for liaisoning with regulatory agencies as CSDO in the area of molecular diagnostic, FDA, EU, AFNOR,ICH, Centre for Disease Control, Clinical Laboratory Standard Institute and nodal agencies like Export Inspection Council, BIS,APEDA, NIN, NABL and ICMR-India.

• Responsible for collaborative partnership with public and private institutions to enhance technology base and for validation trials for global regulatory approvals.

• Led cross-functional teams and developed detailed project plans for laboratory operations to meet

ISO/FDA/CE marking regulatory deadlines for developing transgenic/GMO detection tests for various transgenic crops such rice, corn, cotton and soy etc for various GMO events released in the world market and monitoring the standardized assays and developing new assays as per market demand and clinical diagnostic of infectious diseases and pathogen detection and molecular biology kits and ensured that all regulatory requirements are met on all projects.

• Developed all aspects of corporate projects including project plan, budget & required resources and communicated critical project metrics, such as on time project completion percentages, statistical analysis of project duration with MD, CEO(BioServe-India) President(BioServe-US) and Responsible for conducting R & D in Molecular Diagnostics , Food Diagnostics and genomics(biomarker discovery). In Clinical Diagnostics the focus is on PCR and qPCR based molecular biology kits ( RUO market) on infectious diseases, chronic diseases, pre-natal testing and other esoteric tests.

• Implemented PMI s project management methodology to improve and speed up product development, minimize risk and assure buy-in from the entire development teams –MDx ,Genomics and Regulatory and Business Development.

• Ensured compliance to FDA regulations (CFR Part 11) ,FDA 510 K and ISO specifications and developed Standard Operating Procedures (SOP) and Validation Plans for molecular biology kits for RUO based on Current Good Manufacturing Practices (cGMP).

• Team Management for new product development in the field of molecular diagnostics, Genomics and molecular biology kits and managed and motivated cross-functional team members, including Laboratory Technical Services (LTS), Quality Assurance, Data Review, Documentation & Training, Change Control and Regulatory Affairs to achieve project objectives.

• Communicated issues and delays to upper management in a timely manner and recommended solutions to minimize risk and project delays and developed process improvements and project tracking tools to better notify management of milestone achievements and issues for resolution.

• Developed project management tools and quality control and assurance plans for various project on CRO services like Gene synthesis , oligo sy nthesis SNP,AFLP, SSR,RAPD, Microarrays, sequencing -MegaBace and ,bacterial identification

• Overall in-charge in obtaining and enforcing of ISO 9001:2008,ISO 17025:2005 , ISO 15189:2007(Medical labs) and CE and FDA 510K marking for kits and leading QA and QC efforts and GLP implementation and maintenance

• Responsible for synergizing with other department heads/project teams to establish/improve the new product development process, set goals and standards for the team and create an environment which supports rapid and efficient product development by identifying critical paths and project risks

Key Projects

Development and validation of Molecular Diagnostic Kits-HIV, HCV, HPV and TB

Development and validation of Molecular Diagnostic Kit for H1N1

Detection and quantification of HBV DNA from blood donors by implementing Real time PCR methodology”. a collaborative project with Apollo Hospital

Detection and quantification of cell markers for leukemia and Immuno-phenotyping by Flow cytometry(BD FACS Calibure)

Project on HIV drug resistance project for monitoring the viral load of the patients who are on antiretroviral therapy.

Development of PCR assay for detection of dual infection of both dengue and chikungunya virus in patients

Disease Diagnostics and Molecular Food Safety

Development and validation of Molecular Diagnostic Kits-Pathogens (Conventional and RT-PCR) for various industries such as Water, Food ,diary and pharmaceutical finished products and raw material.( Pathogens: E.coli, shigella. Salmonella, Staph aureus, Vibrio cholerae, Clostridium perfringens, Listeria monocytogenes, Campylobacter coli, Streptococcus faecalis,etc) and GMO tests for events released in the world markets.

Detection of indicator pathogens from pharmaceutical finished products and raw materials using multiplex PCR and comparison with conventional microbiological methods.

Achievements:

Developed and validated Molecular Diagnostic Kits(RT-PCR) for HIV, HCV, HPV, H1N1 , TB dengue and Chikungunya.

Developed RT- PCR based food pathogen testing kit and obtained ISO 17025:2005.

Developed uni-plex, multiplex PCR test for industry specific as well multiple sectors as flora watcher for food pathogens

Developed SAP in Disease Diagnostic testing Operations and initiated H1N1 testing based on CDC protocol

Developed in-house transgenic /GMO detection tests for various transgenic crops in the market place obtained for ISO 17025:2005 (1st time in-house in India)

Developed tests for fish DNA in fish meal for various food exporters and Fish bar coding based on FDA protocol.

Secured business leads with companies like Cadbury, Unilever, Nestle and various hospitals, exporters and various regulatory agencies for market penetration of niche qPCR products , securing distribution, managing media and marketing initiatives regionally and Globally

Set up distribution, sales and marketing infrastructure to cover un-organised biotech sector with reference to molecular biology kits

Initiated collaborative projects with CDC,Atlanta ,US on H1N1,food pathogens and transgenic/GMO tests-Joint Research-EU Centre_Belgium, Thermo Fisher Scientific ,US for development, commercialization of next generation of diagnostic consumables and PCR based tests with Unilver , Cadbury and General Mill Inc

Completed extensive market survey with various hospitals in India for MDx , PCR based testing for GMO , food and water testing and environment monitoring, terrestrial DNA in fish meal for various exporters and for next generation sequencing and oligo synthesis in Indian market and wrote business plan

2. Organization:- Avesthagen Limited, Bangalore-India

Designation:- Functional Head – Genomics and Bio-analytical Biotechnology Services, Genomics and CRO

Team Size:- 8

Roles & Responsibilities:-

• Responsible in executing GMO testing services as per the Genetic ID protocol and contracts related to Business Development.

• Responsible for execution of development of molecular marker projects, marker assisted selection-screening projects.

• Responsible for work with respect to projects concerning plant transgenic and tissue culture of different crops assigned .

• Responsible for molecular biology work

• Responsible for integration with the In-house Knowledge Management System.

• Responsible in helping the Intellectual Property division draft intellectual property applications, where necessary

• Responsible for obtaining and enforcing ISO 17025:2005 in GMO detection lab.

Key Projects

Genotyping of Indian population for Systemic Lupus Erythematosus (SLE) Using Sequenom platform

GMO (Genetically modified organism) Testing Using Genetic ID technologies and techniques , Basmati authentication and DNA based Food pathogen detection Testing operations

Development of PCR based protocol on LOD limit of detection) at 0.01 % for various GMO events using Certified Reference material

DNA finger printing of various crops like maize, Abrus, Genotyping and Sequencing, development of SSR marker in cotton.

Standardization of protocol for transgenic development of rice ,sun flower

Marker Assisted Screening: Molecular breeding of maize for high oil and yield (Marker assisted Selection

Developed and implemented tracking tools for regulatory compliances and Risk Management, Lessons Learned, and Metrics activities in GMO detection, transgenic crop development and molecular breeding projects.

Developed and implemented methods and procedures for managing the status of project milestones, including preparation and delivery of progress reports to inform executive management of current project status.

Provided performance feedback for each participant on the project to appropriate organizational manager.

3. Organization:- DBT, Govt of India, HPU-Shimla

Designation:- Associate

Key Projects

Development of database on microbial resources of HP

4. PhD Thesis

Assessment of Genetic diversity in endangered medicinal plant Podophyllum Hexandrum Royle from Himachal Pradesh using molecular markers (AFLP,RAPD & Isozymes)

5. M.S. Thesis

Agro bacterium mediated genetic transformation studies in cabbage using GUS/Bt gene

Workshops & Trainings Attended

• Attended International Conference on biotechnology (Shimla knowledge.com)7-9june,2001

• Attended two days workshop on "Bio-business for Entrepreneurship and employment Generation: Shimla 19-20, August 2001 organized by department of Biotechnology, HP Govt.

• Attended one day workshop on Bioinformatics-Database Development June 21,2001

• Attended International conference on Biotechnology and Bioinformatics organized by Confederation of Indian Industries February 2-4, 2003

• Attended International Congress on Plant physiology

• Attended international conference on Biotechnology,January9-12,2006,GKVK,Bangalore

• Attended Food safety submit in New Delhi June 11,2008

• Attended Food Ingredient conference in Mumbai October 3 and 4th 2008

• Attended two days training program on advanced techniques in food testing at TUV Bangalore-2008

• Attended two days training program on Basmati authentication at Lab India, Gurgaon -2008

• Attended 3 days training on CD4/CD8 and special course on leukemia at BD BioSciences, Gurgaon, July,2009

• Participated in Frost and Sullivan business submit on Application of Biotechnology in Food and Beverages, July 24, 2009, Mumbai

• Participated FICCI workshop on Biotechnology R and D in food processing sectors , July 31,2009,New Delhi

Scholarships Received

• Nominated for Commonwealth scholarship Plan -UK-2003 in Molecular biology(Bioinformatics)

by Ministry of Human Resources Development Govt. of India

• Selected for six months studentship in Bioinformatics ,sponsored by Dept. Biotechnology,2001Govt. of India, at HP University, shimla-2001

• University Merit Scholarship Holder-PhD

• Selected for SRF (senior Research fellowship ) in biotechnology conducted by Indian Council of Agriculture Research) New Delhi-2001

Computer Proficiency

• Well versed with MS Office 2003 & 2007, Internet and World Wide Web

• Bioinformatics Software: SE Central- Clone Manager 5, Chromas, Primer express 2.0, Primer3, Primo, Webcutter 2.0, BioEdit

• IPR Softwares: Scifinder, Medusa, Ekaswa, Delphion, Micropat, Patentlens, free search sites (USPTO: PATFT & AppFT, esp@cenet, Patentscope, etc.)

Hobbies & Interests

Adventures, Traveling, Studying human behavior, Sports & Reading, Community service, Blood donation

Personal Information

Father’s Name: Late Sh. Prithivi Singh Passport No.: on request

Date of Birth: 10th April 1976 Language proficiency: English, Hindi

Sex: Male, Marital Status: Single * References available upon request

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