Samir Kumar Mandal Email & Phone Number

Hyderabad, Telangana, India

Responsible for Regulatory Strategy for product development, dossier life cycle management, scientific advice packages, audit and compliance, product registration and lifecycle management. Directing CMC Regulatory organization with strategy and managing global development and registration of Biosimilar products for Emerging and Regulated Markets. Accountable for submission dossier as per ICH-CTD requirements for all products, ensuring quality and compliance with filing requirements specific to each region and/or country. Managing product regulatory life cycle for India and Emerging market applications to market approval for global regulatory dossiers. Responsible for due-diligence activities of novel biologics/NBE from potential partner’s. Review, 0f NBE/novel biologics dossier, modification as per country requirements and submissions to different regulatory bodies across the world. Collaborated with cross-functional teams to guide dossier content and offer regulatory insights throughout the product development lifecycle.Presenting in Agency meetings (FDA, EMA, INVIMA, DCGI and others) for technical discussions along with SMEs to align on the development and approvals pathways for biosimilars/Biologics.

Hyderabad Area, India

Accountable for designing, planning and organizing research and development work to establish bio-similarity between similar bio-therapeutics by performing release testing and product characterization.Responsible for designing analytical studies on drug substance (DS) and drug product (DP) and necessary documents to cover CMC of DS and DP in dossier. Experience in the biotechnology and pharmaceutical industry developing biologics (complex glycoproteins, monoclonal antibodies etc.) and peptide products focusing on IND enabling process analytics, method validation strategy, technology transfer, and preparing regulatory CMC and quality sections. Accountable for creating and reviewing documents for method development approach, physiochemical comparability plan, method validation strategy, specification set-up, reference standard creation for early and late clinical phase products and process development. Accountable for designing, planning and organizing research and development work to establish bio-similarity between similar bio-therapeutics by performing release testing and product characterization. Responsible for designing analytical studies on drug substance (DS) and drug product (DP) and necessary documents to cover CMC of DS and DP in dossier. Experience in the biotechnology and pharmaceutical industry developing biologics (complex glycoproteins, monoclonal antibodies etc.) and peptide products focusing on IND enabling process analytics, method validation strategy, technology transfer, and preparing regulatory CMC and quality sections.

Hyderabad Area, India

Responsible for planning and organizing analytical development for bio-therapeutics.Manage(ing) and closely supervise(ing) groups of analytical and bioassay scientists working towards (1) to development, qualification and validation analytical methods for release and process development support including HPLC, mass spectrometry, gel electrophoresis, excipient analysis, carbohydrate assays (glycan map) and (2) towards creation of Reference standard, reference product survey, new technology assessment and qualification Accountable for designing, planning and organizing research and development work to establish bio-similarity between similar bio-therapeutics by performing release testing and product characterization.Responsible to create a common platform for effective collaboration to investigate the discrepancies pertaining to products in the development and commercial space.Accountable for creating and reviewing documents for method development approach, physiochemical comparability plan, method validation strategy, specification set-up, reference standard creation for early and late clinical phase products and process development.

Hyderabad Area, India

Hyderabad Area, India

Managed and closely supervised a group of Analytical scientists to develop and qualify analytical methods for release, physiochemical characterization for toxicity studies and process development at the early stage of product life cycle management.

Hyderabad Area, India

Responsible for cGMP Technical Operations for release of raw material and packing material; testing and commercial release of API and finished commercial biological product products. Responsible for planning and conducting stability studies to monitor product shelf life; and evaluating method robustness by utilizing performance.Building capabilities in discrepancy investigation, method troubleshooting, method validation and technology transfer.

Tyler, Texas Area

Tissue factor (TF)-dependent blood coagulation plays an important and primary role in hemostasis after tissue injury and also in pathogenesis of many thrombotic events, like atherosclerosis, acute coronary syndrome, septicemia, and cancer. My post-doctoral work was primarily focused on the (i) endocytosis and intracellular trafficking pathways of TF and VIIa; (ii) how alterations in cell membrane affects the functional expression VIIa/TF and (iii) delineating VIIa-induced signaling process and its relevance to pathophysiology. The studies not only defined the key processes involved in the initiation and regulation of blood clotting, but also raised novel possibility that tissue factors may also contribute to various cellular processes, independent of blood coagulation.

Post Doctoral Study, Hematology (Blood Coagulation)

Doctor Of Philosophy (Phd), Biochemistry And Cell Biology

Activities and Societies: Ph.D work in Indian Institute of Chemical Biology

Master'S Of Science, M. Sc, Biochemistry

Bachelor Of Science, B. Sc, Chemistry (Major), Physics, Mathematics, Statistics