プロフィール詳細

プロジェクトを作成

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Lakshmi Deepthi S.に依頼

India

Freelance Senior CMC Regulatory Specialist | Biologics Drug Development and CMC Strategy | 15 years experience

プロフィール概要

15 years of experience in Biopharmaceutical/Biosimilar industry with end to end understanding of product development, CMC regulatory strategy and Product Life Cycle Management, wherein the initial 8 years of experience was in physicochemical, structural and biological characterization, technology transfer, stability, analytical method development and validation for a wide spectrum of biosimilars/biologics including monoclonal antibodies, fusion proteins, colony stimulating factors and insulin analogs; the later 7 years being associated with CMC writing, regulatory strategy and regulatory affairs. Currently working as freelance Senior Regulatory Specialist providing services in the domain of CMC Regulatory including technical and scientific writing from December 2021. Previous work experiences include Head, Regulatory Operations and Analytical, at a scientific and technical consulting start-up viz. Integrated Biopharma and Pharma Solution (IBPS consulting), Senior Research Scientist III (Assistant General Manager) in CMC domain of Regulatory Sciences function acting as SME for Product Quality and Regulatory Strategy at Aurobindo Biologics (now CuraTeQ Biologics), a unit of Aurobindo Pharma Ltd and Senior scientist, Analytical and formulations development, Biologics, DR. Reddy’s Laboratories. Proven experience in demonstrating effective cross-functional collaboration across the functions viz. Analytical, Process Development, Quality Control and Regulatory CMC for strategic alignment with the organizational goals.  Expertise in authoring and reviewing dossier required for global regulatory submission e.g., scientific advisory briefing book, IND/IMPDs, CTD dossier preparation (Module 2, 3, 4 and 5) and framing appropriate responses to regulatory queries. Expertise in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data. Working closely with Regulatory Affairs to ensure appropriate alignment of strategies, driving communications based on scientific rationale to obtain buy-in of regulatory agencies. Expertise in Quality by Design CMC development concepts of biopharmaceuticals e.g. Quality Target Product Profile, FMEA model for CPP and CQA identification and Analytical Similarity Assessment approach. Expertise in Analytical method development and validation concepts, specification settings for lot release, impurity analysis and stability testing, technology transfer procedures and monitoring the life cycle of the method. Stability study design and data trending/evaluation as per ICH guidelines. Expertise in Analytical similarity assessment study design with appropriate statistical approaches relevant for biosimilars. Expertise in product characterization with thorough understanding of structure function relationship for biosimilars. Designing extractables, leachables and container closure system studies for Biologics. Expertise in cell bank characterization as per the regulatory expectations. Good knowledge and current awareness of cGMP requirements, global regulations, guidance documents, industry standards and scientific literature pertaining to biologics product development.

専門分野

• ★ Biologic & Biosimilar Development
• ★ CMC Documentation

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Technical Writing, Copywriting

Research Market Research, User Research, Gap Analysis, Gray Literature Search, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Product Development Stability/Shelf Life Testing, Product Validation

職務経験

Functional Head (CMC Regulatory)

Integrated Biopharma And Pharma Solution (IBPS Consulting)

6月 2020 - 11月 2021

Assistant General Manager (CMC Regulatory)

Aurobindo Biologics

7月 2016 - 5月 2020

Senior Scientist

Dr. Reddy's Laboratories (India)

7月 2007 - 6月 2016

学歴

Masters in Biotechnology

University of Madras

6月 2004 - 4月 2006

認定資格

• 認定資格の詳細は未入力です。