Sabitur Rahman

WORK HISTORY

EDUCATION

SKILLS

ABOUT SABITUR RAHMAN

Strategic CMC leader with deep expertise in pharmaceutical development, technology transfer, GMP industrialisation, regulatory affairs, and quality assurance across radiopharmaceuticals, NBEs, NCEs and biotherapeutics. I bring over two decades of experience translating complex scientific challenges into streamlined, compliant, and commercially viable solutions—driving global programs from early-phase development through NDA/MAA submissions and lifecycle management.My leadership spans formulation and analytical development, GMP manufacturing, and cross-functional program execution, with a proven track record of delivering high-impact Module 3 content for INDs, IMPDs, and NDAs. I’ve led CMC operations for small molecules, peptides, and live biotherapeutic products across Phases consistently aligning technical excellence with strategic business goals.I specialise in taking processes from R&D into GMP — stabilising early manufacturing, resolving on‑floor technical issues, scaling processes, executing PPQ, and building the operational frameworks that enable reliable clinical and commercial supply.I’ve led global CMC and Technical Operations functions across DS/DP development, analytical validation, GMP manufacturing, supply chain, and regulatory strategy, delivering high‑impact Module 3 content for IND, IMPD, NDA, and MAA submissions. My leadership style blends scientific depth with operational discipline, ensuring that technical excellence aligns with strategic business goals.Known for clarity, precision, integrity, cross‑functional influence and collaborative leadership, I build high‑performing teams, strengthen CDMO partnerships, and drive industrialisation strategies that accelerate timelines and reduce risk. Whether optimising product development workflows, guiding global tech transfers, or preparing assets for commercial readiness, I operate with a relentless focus on quality, efficiency, and execution.Specialties• Key strengths in CMC, Drug Development, Regulatory Affairs, Client Relationships, and Project Management, with deep specialization in the pharmaceutical industry and clinical supplies.• Managing clinical supply requirements for pharmaceutical development companies across local, national, and global scales, supporting all phases of drug development.• Leading a large portfolio of global clients, consistently delivering complex, multi-phase projects with precision and strategic alignment.