Selvaraj Vellaisamy Email & Phone Number | A biotechnologist having Master in Microbiology and Doctorate in Biotechnology background having more than 27 years of industrial experience in India as well as USA from green field project to commercialization (drug substance/API/drug products) products like recombinant protein, fusion proteins, monoclonal antibodies, industrial enzymes and biopolymers. Establishment of several green field project from R&D, Pilot plant, Manufacturing facility and quality operation infrastructure as per the global regulation requirement. Comprehensive knowledge of biological products development from gene cloning and expression, bioprocess development (upstream and downstream) biosimilar characterization and optimization, process/cleaning validation and technology transfer, manufacturing, preclinical and clinical development, regulatory filling and complete lifecycle management of biologics. Proven track record in biological drug product manufacturing under cGMP/cleanroom environment formulation, fill and finish in PFS, Cartridge and Vials and drug stability protocol preparation, execution, and submitting the data to various regulatory authority. Sound knowledge of various functions like R&D, QA, QC, RA, Purchase, Store, warehouse, engineering ( water system, HVAC, compressed air) and identifying bottleneck and excellent technical problem solving to continuous improvement. Writing/reviewing/approving various documents like SOPs, STPs, protocols, MFR, BMR, BPR, concept note, report, summaries, deviation, OOS, OOT, change control and CAPA etc Common technical dossier (CTD) preparation and submitting the dossier to various regulatory authorities for getting manufacturing and marketing authorization. Over 15 biological products ( recombinant protein and monoclonal antibodies drug substance and drug products, industrial enzymes, industrial biopolymer) from development stage to commercialization. Understanding overall operations for new products or improvement of existing products by efficient usage of available resource, improving manufacturing efficiency and cost reduction without compromising the product quality Effective project planning, mapping, financial budgeting for operation and new project development, supplier interaction and supplier management. Leading, managing and monitoring the performance of team members to ensure and follow the time line and milestone and deliverable as per the project plan

Selvaraj Vellaisamy

A biotechnologist having Master in Microbiology and Doctorate in Biotechnology background having mor...
Chennai, Tamil Nadu, India

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Selvaraj Vellaisamy’s Email sselvarajv@yahoo.co.in

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Selvaraj Vellaisamy’s Location Chennai, Tamil Nadu, India

Selvaraj Vellaisamy’s Current Industry Regenix Drugs

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Work Experience

Regenix Drugs

Vice President Project, Technical cum Operation ( Biologics) Injectable Plant

2020-09-01 00:00:00 - Present

Delta Biopharma

Vice President Project, Technical cum Operations (Biologics) Injectable Plant

2019-01-01 00:00:00 - 2020-08-01 00:00:00

Microtherapeutic Research Lab

Vice President Technical cum operation (Biosimilar and Preclinical)

2015-01-01 00:00:00 - 2018-01-01 00:00:00

Marshall University

Research Director for Nanomedicine

2010-01-01 00:00:00 - 2015-01-01 00:00:00

Vivo Bio Tech

General Manager Technical cum Operation

2009-01-01 00:00:00 - 2010-01-01 00:00:00

Orchid Chemicals And Pharmacutical

Senior Manager

2008-01-01 00:00:00 - 2009-01-01 00:00:00

Operon Biotech

Senior Manager/Head Operation

2006-01-01 00:00:00 - 2008-01-01 00:00:00

Sgs Chemical Solutions Laboratories

Manager/Head for Biotechnology, Microbiology and Toxicology

2004-01-01 00:00:00 - 2006-01-01 00:00:00

Spic Biotechnology Division

Senior Research Associate

1995-01-01 00:00:00 - 2004-01-01 00:00:00

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FAQ About Selvaraj Vellaisamy

Selvaraj Vellaisamy is located at
Chennai, Tamil Nadu, India

Selvaraj Vellaisamy is a A biotechnologist having Master in Microbiology and Doctorate in Biotechnology background having more than 27 years of industrial experience in India as well as USA from green field project to commercialization (drug substance/API/drug products) products like recombinant protein, fusion proteins, monoclonal antibodies, industrial enzymes and biopolymers. Establishment of several green field project from R&D, Pilot plant, Manufacturing facility and quality operation infrastructure as per the global regulation requirement. Comprehensive knowledge of biological products development from gene cloning and expression, bioprocess development (upstream and downstream) biosimilar characterization and optimization, process/cleaning validation and technology transfer, manufacturing, preclinical and clinical development, regulatory filling and complete lifecycle management of biologics. Proven track record in biological drug product manufacturing under cGMP/cleanroom environment formulation, fill and finish in PFS, Cartridge and Vials and drug stability protocol preparation, execution, and submitting the data to various regulatory authority. Sound knowledge of various functions like R&D, QA, QC, RA, Purchase, Store, warehouse, engineering ( water system, HVAC, compressed air) and identifying bottleneck and excellent technical problem solving to continuous improvement. Writing/reviewing/approving various documents like SOPs, STPs, protocols, MFR, BMR, BPR, concept note, report, summaries, deviation, OOS, OOT, change control and CAPA etc Common technical dossier (CTD) preparation and submitting the dossier to various regulatory authorities for getting manufacturing and marketing authorization. Over 15 biological products ( recombinant protein and monoclonal antibodies drug substance and drug products, industrial enzymes, industrial biopolymer) from development stage to commercialization. Understanding overall operations for new products or improvement of existing products by efficient usage of available resource, improving manufacturing efficiency and cost reduction without compromising the product quality Effective project planning, mapping, financial budgeting for operation and new project development, supplier interaction and supplier management. Leading, managing and monitoring the performance of team members to ensure and follow the time line and milestone and deliverable as per the project plan

Selvaraj Vellaisamy currently works in the Regenix Drugs |

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Selvaraj Vellaisamy has prior
experience in the following industries:
Delta Biopharma | Microtherapeutic Research Lab | Marshall University | Vivo Bio Tech | Orchid Chemicals And Pharmacutical | Operon Biotech | Sgs Chemical Solutions Laboratories | Spic Biotechnology Division

Selvaraj Vellaisamy has the following professional experience:
Regenix Drugs | Delta Biopharma | Microtherapeutic Research Lab | Marshall University | Vivo Bio Tech | Orchid Chemicals And Pharmacutical | Operon Biotech | Sgs Chemical Solutions Laboratories | Spic Biotechnology Division