Mohammad Azim

Background

About Mohammad Azim

Dedicated and results-driven professional with a proven track record in transforming R&D laboratories into high-performance quality control hubs for ISO 13485 certified medical devices companies. As an ISO 13485:2016 Lead Auditor with expertise in ISO 9001, 21 CFR 211 & 820/GMP, I excel in ensuring stringent compliance and optimal operational efficiency. In my leadership role, I guided the Research and Development team in designing innovative products, collaborating with Key Opinion Leaders (KOLs) to shape product specifications. I have successfully developed and validated over 12 analytical test methods, aligning them with USP, JP and ICH guidelines, and authored comprehensive SOPs for methods and instruments. With a background spanning more than 12 years in academic and industrial research, I have successfully released products utilized in Phase-I First in Human safety clinical trials and slated for Phase clinical trials. Beyond my technical skills, my leadership shines through various roles, including serving as President for the Bangladesh Student Association and Michener Park Residents’ Association at the University of Alberta. Additionally, I contributed as a board member to the Postdoc Teaching Opportunities program at UC Berkeley. My strengths lie not only in technical prowess—showcased through expertise in analytical instruments, biology/biochemistry, design, microfabrication, and microfluidics—but also in effective communication and interpersonal skills honed through managing quality control teams, teaching undergrad students, and active participation in community volunteer activities.