Hire Dr. Md. Hanif S. Shaikh, a pharma consultant specializing in Analytical Testing, Clinical Studies, Drug Development and Pharmaceutical Manufacturing. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Dr. Md. Hanif S. Shaikh is a pharmaceutical research and development professional specializing in API process development, new chemical entity development, process optimization, scale-up, and technology transfer. His expertise aligns with API Process Development, Analytical Development, Process Validation, Chemistry, Manufacturing and Controls (CMC), and Regulatory Filing support. His career includes roles with Aurobindo Pharma, Vamsi Labs, Alkem Laboratories, Glenmark Pharmaceuticals, and Evotec India. He brings experience applying Quality by Design and Design of Experiments, evaluating synthetic routes, characterizing impurities, and supporting nitrosamine and genotoxic impurity risk assessments. His contributions include process development and technical documentation supporting US DMF and CEP filings. He helps pharmaceutical teams develop scalable manufacturing processes and address technical challenges from laboratory development through commercialization. - Show More
Hanif supports analytical development through impurity synthesis, characterization, forced degradation studies, and impurity profiling. His experience includes identifying and synthesizing unknown impurities using relative retention time and LC-MS investigations, alongside nitrosamine and genotoxic impurity risk assessments. He works with analytical and development teams to investigate impurity-related challenges and generate supporting information for API development and regulatory submissions.
Hanif supports API process development from synthetic route evaluation and optimization through scale-up, technology transfer, and commercialization. His experience includes patent evaluation, development of non-infringing routes, and application of Quality by Design and Design of Experiments. He helps teams improve process robustness, manufacturing feasibility, and cost efficiency while addressing plant troubleshooting and product lifecycle requirements.
Hanif supports CMC activities through API process development, impurity characterization, manufacturing process optimization, and preparation of supporting technical documentation. His experience includes collaboration with analytical development, quality assurance, regulatory affairs, and plant production teams. He helps organizations connect process knowledge and impurity assessment findings with manufacturing and quality information required for product development and regulatory submissions.
Hanif supports API process validation through experience coordinating plant validation, scale-up, technology transfer, and manufacturing troubleshooting. His development work applies Quality by Design, Design of Experiments, and statistical techniques to improve process robustness. He helps development and manufacturing teams translate laboratory processes into plant operations and address technical issues during validation and commercialization.
Hanif supports regulatory filing through process development contributions and technical documentation for US Drug Master Files and Certificates of Suitability. His career includes contributions to 11 US DMFs and three CEPs. He helps regulatory teams compile API process information, impurity-related findings, and supporting development records for submission and product lifecycle activities.
