Mike Wisler
About Mike Wisler
Mike Wisler is the Director of Life Science Commissioning with extensive experience in FDA regulated industries, specializing in the design, construction, and qualification of ISO 5-8 cleanrooms.
Title: Director of Life Science Commissioning
Mike Wisler holds the position of Director of Life Science Commissioning. In this role, he oversees the commissioning processes within the life sciences, ensuring that procedures and systems are fully functional and meet required standards. His responsibilities include spearheading major projects and ensuring compliance with industry regulations, particularly those set forth by the FDA.
Education and Expertise in FDA Regulated Industry
With 20 years of experience in the FDA regulated industry, Mike Wisler possesses deep expertise in this crucial area. His extensive knowledge spans various aspects of this industry, focusing on vaccine production and the manufacturing of both liquid and solid dose drugs. This experience underscores his role in ensuring that life science commissioning processes meet stringent regulatory requirements.
Background: Engineering and Design Oversight
Mike Wisler brings 25 years of operational and consulting experience to his role, including 15 years dedicated to the oversight of design, construction, and qualification of ISO 5-8 cleanrooms. His engineering expertise was vital in leading efforts on a pandemic flu readiness facility. Over his career, he has managed and directed various projects, ensuring that facilities are designed and constructed to meet high standards.
Roles in the Pharmaceutical and Biopharma Industries
Mike Wisler's project experience includes work in both the pharmaceutical and biopharma industries, contributing to both research and commercial manufacturing. He has held multiple leadership and specialist roles such as regional and department director, project director, project manager, commissioning lead, validation lead, and validation engineer. His comprehensive role history highlights his versatility and depth of knowledge in these fields.
Senior Leadership in FDA Licensed Manufacturing Facilities
Mike Wisler was also a member of the senior leadership team at two FDA licensed manufacturing facilities. In these roles, he played a significant part in overseeing and ensuring compliance with industry standards. His leadership contributed to the operational success and regulatory adherence of these facilities, underscoring his capability to operate at the highest levels of the life sciences sector.