Alexander Hermann, PhD

Alexander holds a Master’s degree and a PhD in Inorganic Chemistry. He started his career at NAMSA in June 2020, focusing on medical devices in the field of Extractables & Leachables (E&L) Testing. He has specific expertise in Chemical Characterization programs based on ISO 10993-18, as well as US FDA and other country expectations for the development of study designs.

CORE COMPETENCIES

• Providing leadership, planning, coordination, and oversight of the Study Director Group at NAMSA Obernburg
• Ensuring studies are conducted according to applicable regulations and procedures with a high ethical/quality of standards
• Overseeing study execution to ensure studies are completed on time, within budget, and in compliance with SOPs, guidelines, and applicable regulations
• Coordinates study conduct tasks from study initiation to study completion
• Ensuring high communication standards and interactions with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments
• Developing and leading complex study designs and protocols
• Supporting client calls and answering client questions on study designs
• Supporting special testing (protocol/report creation, discussion with clients)
• Attending and presenting at E&L and medical device conferences
• Supporting Nonconformance and CAPA investigations

RECENT PROJECTS

• Managing studies focused on Hospital Care Devices, specifically intended for Infusion, Nutrition, and Pain Therapy
• Deep Involvement in FDA related deficiencies in the field of Chemical Characterizations