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