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Manjunath HS
Manjunath HS

The document provides a profile summary of an individual with a Masters in Biochemistry and nearly 17 years of experience in research and development, operations management, quality management, and regulatory affairs in the biotech and biopharma industries. They have expertise in developing processes for biosimilars, diagnostic products, and biosensor assays and an in-depth understanding of regulatory guidelines. They are also skilled in designing and implementing R&D processes according to regulatory requirements, analyzing research results, and ensuring compliance with good practices.

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______________________________________PROFILE SUMMARY_______________________________________________ Masters in Biochemistry with nearly 17 years of comprehensive experience in Research & Development, Operations Management, Quality Management and Regulatory Affairs in the Biotech: biopharma & diagnostics industries. Successfully executed various research projects involving planning, execution, application of methodologies while demonstrating precision & accuracy in data collection; proficient in analysing and interpreting research results and technical data; possess expertise in method development and validation. Skilled in designing, development and implementation of commercially viable, safe & eco-friendly R&D processes as per regulatory requirement within stipulated timeline. Rich experience in developing processes of biosimilars, diagnostic products and biosensors assays. Acquired in-depth understanding of regulatory guidelines of EMEA, FDA, RCGM, DCG and cGMP& GLP requirements. Adept in prioritising significant work load while consistently meeting project deadlines; rich experience in working within a group with people of diverse technical and cultural background while demonstrating leadership quality. Result-focused Team Player with excellent written & verbal communication skills and strong analytical, problem solving & organisational abilities; possess a flexible & detail oriented attitude. ______________________________________DOMAIN EXPERTISE_______________________________________________ ? Transpeptidation, Conjugation and Crystallisation Process of Recombinant Therapeutic Proteins like Insulin, Glargine, Oral Insulin (IN-105), Aspart & Lispro ? Column Chromatography, Enzymatic Reactions, Amidation Conjugation PEGylation Reactions, Biotinylation of Insulin and Insulin Analogs ? Development of Reagent Formulations End Point, Kinetic & Immunoturbidometric Assays), Lateral Flow, Rapid Flow, and Elisa Formulations ? Enzymatic Peptide Amidation - Exendine and BNP Molecules process development ? Protein Purification of Intracellular and Extra-cellular Recombinant Proteins _______________________________________CORE COMPETENCIES_____________________________________________ ? Planning & organizing day-to-day research activities and resolving procedural problems; organising ideas and materials in effective ways; collaborating with people from across the organization to complete the research objective on time MANJUNATH H. S. Mobile: +91 - 8968514360 E-Mail: manjunath0312@gmail.com
? Collaborating with people in multi-country platform to coordinate experiments and publication write-up while complying with project deadline ? Ensuring that all appropriate procedures and standards as per GLP regulations are followed for the collection & preservation of analytical samples; maintaining state-of-the-art research techniques and equipment ? Assisting laboratory management by analyzing of capabilities of various service providers, influencing decisions in selection of service providers; presenting acquired data and results to world-class scientific communities ? Promoting quality and performance improvement throughout the organisation; achieving quality certification as per ISO 9000/13485 and ISO 14971 : 2012 standards as well as appraising status of implementation ? Developing a framework of quality standards and overseeing smooth implementation of the same; formulating and managing the development & implementation of goals, policies, procedures & systems pertaining to the R&D, QA/ QC and production ? Supervising, compiling & submitting regulatory dossiers; liaising with sponsors, investigators and vendors; coordinating with Regulatory Department for timely submission of dossiers and provision of response to regulatory queries

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Summary

  • 1. ______________________________________PROFILE SUMMARY_______________________________________________ Masters in Biochemistry with nearly 17 years of comprehensive experience in Research & Development, Operations Management, Quality Management and Regulatory Affairs in the Biotech: biopharma & diagnostics industries. Successfully executed various research projects involving planning, execution, application of methodologies while demonstrating precision & accuracy in data collection; proficient in analysing and interpreting research results and technical data; possess expertise in method development and validation. Skilled in designing, development and implementation of commercially viable, safe & eco-friendly R&D processes as per regulatory requirement within stipulated timeline. Rich experience in developing processes of biosimilars, diagnostic products and biosensors assays. Acquired in-depth understanding of regulatory guidelines of EMEA, FDA, RCGM, DCG and cGMP& GLP requirements. Adept in prioritising significant work load while consistently meeting project deadlines; rich experience in working within a group with people of diverse technical and cultural background while demonstrating leadership quality. Result-focused Team Player with excellent written & verbal communication skills and strong analytical, problem solving & organisational abilities; possess a flexible & detail oriented attitude. ______________________________________DOMAIN EXPERTISE_______________________________________________ ? Transpeptidation, Conjugation and Crystallisation Process of Recombinant Therapeutic Proteins like Insulin, Glargine, Oral Insulin (IN-105), Aspart & Lispro ? Column Chromatography, Enzymatic Reactions, Amidation Conjugation PEGylation Reactions, Biotinylation of Insulin and Insulin Analogs ? Development of Reagent Formulations End Point, Kinetic & Immunoturbidometric Assays), Lateral Flow, Rapid Flow, and Elisa Formulations ? Enzymatic Peptide Amidation - Exendine and BNP Molecules process development ? Protein Purification of Intracellular and Extra-cellular Recombinant Proteins _______________________________________CORE COMPETENCIES_____________________________________________ ? Planning & organizing day-to-day research activities and resolving procedural problems; organising ideas and materials in effective ways; collaborating with people from across the organization to complete the research objective on time MANJUNATH H. S. Mobile: +91 - 8968514360 E-Mail: manjunath0312@gmail.com
  • 2. ? Collaborating with people in multi-country platform to coordinate experiments and publication write-up while complying with project deadline ? Ensuring that all appropriate procedures and standards as per GLP regulations are followed for the collection & preservation of analytical samples; maintaining state-of-the-art research techniques and equipment ? Assisting laboratory management by analyzing of capabilities of various service providers, influencing decisions in selection of service providers; presenting acquired data and results to world-class scientific communities ? Promoting quality and performance improvement throughout the organisation; achieving quality certification as per ISO 9000/13485 and ISO 14971 : 2012 standards as well as appraising status of implementation ? Developing a framework of quality standards and overseeing smooth implementation of the same; formulating and managing the development & implementation of goals, policies, procedures & systems pertaining to the R&D, QA/ QC and production ? Supervising, compiling & submitting regulatory dossiers; liaising with sponsors, investigators and vendors; coordinating with Regulatory Department for timely submission of dossiers and provision of response to regulatory queries