Mahbubur Rahman

Background

About Mahbubur Rahman

Biopharmaceutical analytical and formulation development expert with 25 years (19 years Biopharma Industries, 6 years Academia) technical and scientific leadership including 15 years managerial experience with managing a team of 20 scientists working on analytical and formulation development, qualification and validation to support manufacturing process development, process characterization, process validation/PPQ campaign (Drug substance and Drug product) and commercial operation and technology transfer to commercial sites and CMOs. Proven track record of directing phase appropriate (preclinical to phase I, II, and commercial operation) product analytical and formulation supports for biologics drug candidates for the treatment of oncology and infectious disease. Oversight strategy and planning for all analytical and formulation activities to support new business opportunities and due diligence, CMC development, harmonize process and best practices across new products and global commercial products. Specialties: • Directing physicochemical, analytical and biochemical characterization including higher order structure (HOS) of biologics DS, DP, in-process and critical intermediates. • Management of analytical method and DP formulation design, development, qualification, validation, and transfer activities. • Oversight implementation of analytical and DP formulation technologies in commercial sites and CMOs for phase I, II & clinical product development. • Directing analytical control strategy to support DS and DP manufacturing process QbD development, optimization, characterization, CQAs identification, specifications, scale-up operation, qualification, and validation (PPQ). • Directing analytical and DP manufacturing part of CMC development, authoring ICH Module 3 Quality for INDs and BLAs for global regulatory filings. • cGMP, ICH, FDA, and EMEA guidelines, regulatory compliance, and quality management.