Harikesh Janmanchi

• Mentored team members to enhance professional development and accountability in workplace.
• Developed loyal and highly satisfied customer base through proactive management of team customer service strategies.
• Generated repeat business through exceptional customer service and responded to customer concerns with friendly and knowledgeable service.
• Actively engaged in providing response to query raised by different regulatory agencies (USFDA, EMA, etc.)
• Preparation and review of SOPs to smoothen the process of day today lab activities
• Design and planning of bioassay for various peptides and MAbs as per the Customer requirement referring relevant USP chapters
• Planning for Validation of bioassays using USP chapter 1033 and ICH Q2R guidelines
• Preparation of various protocols and reports to support timely delivery of the Projects
• Investigator for routine Incidents and Deviations and preparation and execution of CAPA.

• Planning of Biosimilarity studies of various Biopharmaceuticals
• Performed research into study topics to increase knowledge and to provide valuable contributions.
• Planning of experiments for method development, validation and sample analysis (Stress studies, batch release, etc.) of various Biopharmaceuticals ensuring its smooth execution
• Preparation and review of Method development reports, Method qualification reports, Technology transfer documents, Developmental method of analysis report, Method of Analysis report, Data recording sheets, Standard Operating Procedure, User requirement specifications, etc
• Development and Qualification of batch release and characterization assays for various biomolecules ranging from hormones to peptides to MAbs
• Transfer of methods to Quality Control Department
• Routine maintenance of a wide varieties of cell lines along with preparation of Master and Working cell bank.

• Development and validation of bioassay for detection of innate immune response modulating impurities (IIRMI) on stimulation with biopharmaceuticals using an array of recombinant cell lines
• Planning and execution of bioassays and Immunoassays right from establishing proof of concept, development and optimization of various aspects leading to a highly reproducible assay along with Validation as per relevant USP chapters and ICH guidelines
• Worked on a wide array of cellular assay formats like cell proliferation and inhibition assay, drug neutralization assay, secondary messenger (determination of cAMP) assay etc) for Biopharmaceuticals
• Development of metabolic functional assays for insulin and insulin analogues using mouse embryonic fibroblast cell line
• Read literature related to scientific area of expertise to remain current in knowledge.

• Method development, optimization and validation of Bioassay (cell proliferation, Neutralization assay, cAMP assay etc) for Biopharmaceuticals
• Method development, optimization and validation of Immunoassays (ELISA’s like sandwich, direct and bridge ELISA for immunogenicity of Biopharmaceuticals
• Routine maintenance of cell lines.

• Lab scale (shake flask) and pilot scale study for production of enzymes using different fungal cultures
• Worked on production of enzymes like Acid protease, Lipase, Pectinase etc. used in food and detergent industry.

• Setting up Molecular biology Nucleic Acid Testing (NAT) laboratory in hospitals and blood banks across Mumbai
• Training laboratory technicians in NAT
• Coordination with sales people for promotion of the product
• Technical support, Documentation.

GPA: 75.80%

GPA: 84.67%