Santanu Singhamahapatra

Aim towards higher growth and better prospects for the company. My objective is to attain progress in research and development in Biopharma & Biotechnology sectors by achieving the targets through enhanced productivity and commitment for the organization. I am adept at multi-disciplinary jobs and flexible in teamwork. Profile Summary: A highly motivated and energetic, dynamic analytical research development and quality control professional with 16 years of work experiences. I am results driven, with attention to detail, with strong interpersonal, technical and communications skills. Professional Experiences: Total 16 plus years of work experiences in the fields of Analytical method development, validation and transfer. Cell culture, GMP Manufacturing, Quality Assurance, Analytical R&D, Cell based Bioassay, Cell Biology, Cell Therapeutics Molecular Biology, Immunology, Microbiology, Immunology, Antibody therapeutics and Regulatory Affairs. Analytical methods development, qualification and validation for Cell Therapeutics products, Biosimilars, Monoclonal Antibodies, Human Therapeutics and Biologics. Antibody characterization to derive pre-clinical and clinical values from antibody platform technology. Working closely with the Scientific team for running optimize and trouble-shoots of different types of cell-based assays designed to further characterize cellular function of antibodies identified from a target-agnostic phenotypic screening assay cascade. Faced & experienced various types of regulatory audits like US-FDA, TGA, EDQM, Indian-FDA, RCGA, EMEA, HMA, MHRA, ANVISA, NCID, WHO, FHI360, European and other regulatory audits. Extensive Knowledge on QC-GMP manufacturing, all types of Bioassays, immunogenicity assays, analytical assays, people management, client management, project management, data analysis and reporting. Trained and certified by United States of Pharmacopeia for Development and Validation of Biological cell-based bioassays. Lean Six Sigma black belt certified. Technical competencies and inter- personal skills: Design assays/experiments, verify, qualify, and validate assays as per requirements within the target timeline Maintain/compile/archive records, process logs, asset logs, soft copy of QA approved data, ATRs and lab notebooks. Supervise and manage function specific inventory, material supply and equipment upkeep along with personnel responsible for this activity. The management of QC team with instrument & consumable suppliers/vendors, engineers etc to complete installation, qualification, calibration, PM, AMC etc. on time. Ensure compliance with GLP/GMP practices & safety norms, standardize operating procedures and guidelines Good knowledge and hands-on experience in carrying out immunoassays, cell-based assays for therapeutic proteins are essential. Good team player with sound troubleshooting skills. Experience with project management, lab management and documentation in pharmaceutical/ biopharmaceutical industry setting (not mandatory). Established track record in form of publications and/or patents or experience in Industry (Biopharma or cell and Gene therapy) and familiar with working in GMP environment Team management about. Having experience in day-to-day planning for Bioassay analysis, methods transfer, validation. Experience in handling QMS likes-Laboratory Incident Investigation, Deviation investigation and Change control and CAPA. Knowledge and hands-on experience of carrying out immunoassays, in vivo and invitro assays for therapeutic proteins. Good documentation practices using MS office Good oral and written communication Analytical thinking Knowledge on handling of cell lines and all routine tissue culture practices, cell-based assays, ELISA, reporter cell line-based assays, Immunophenotyping, HCDNA, Mycoplasma et Experience in working with potency and effector function determining bioassays for biologics. Versatile Senior Manager specializing in [Area] and skilled at planning, implementing and overseeing key improvements to drive business growth and efficiency. History of cultivating an open culture with free exchange of information. Pursuing new professional challenges with a growth-oriented company. Encouraging manager and analytical problem-solver with talents for team building, leading and motivating, as well as excellent customer relations aptitude and relationship-building skills. Proficient in using independent decision-making skills and sound judgment to positively impact company success. Dedicated to applying training, monitoring and morale-building abilities to enhance employee engagement and boost performance.

• Experience on software such as graph pad prism, Gen 5, PLA, SoftMax pro, Quanto Studio 5, Step one plus, EDMS, Track Wise, ELN, SAP
• Knowledge of software such as Flow jo, Incyte, Guava soft, Aria Max etc
• Should preferably have functional knowledge of animal bioassays for assessing methods and support investigations
• Cell culture: Regular maintenance of various cell lines (Kasumi-3, Raji, HeLa, MOML13, CT26, LNCap,22RV1, MV411, SKOV3, SKBR3, MCF, SKW3, A549, OVICAR, SUPT1, T3, Raji Cells, CHOK1, MDAMB-231, H929, HEK-293, CT-26), B-Cell lines, T-Cell lines, SpO2, CHO, BHK