Marshall Parker serves as the Director of Quality at Cygnus Technologies, LLC, where he plays a pivotal role in ensuring the highest standards of quality and compliance within the biopharmaceutical industry. With a robust background that spans from quality engineer to his current leadership position,...
Marshall Parker serves as the Director of Quality at Cygnus Technologies, LLC, where he plays a pivotal role in ensuring the highest standards of quality and compliance within the biopharmaceutical industry. With a robust background that spans from quality engineer to his current leadership position, Marshall has successfully led the Biologics/Drug Platform, focusing on Class II and III product development, commercialization, and sustaining activities. His expertise is instrumental in driving global Quality Management System (QMS) harmonization, which is essential for maintaining regulatory compliance across diverse markets.
At Cygnus Technologies, part of Maravai LifeSciences, Marshall is deeply involved in key projects that support the development of therapeutic proteins, vaccines, antibodies, and gene therapies. His strategic leadership extends to his membership in the BD Biosurgery global Business Unit Quality Leadership Team and Product Steering Committees, where he contributes to enterprise-level strategic direction and due diligence support for acquisitions. His proficiency in Quality Systems, including ISO 13485 and 21 CFR Part 820, ensures that Cygnus Technologies adheres to the highest regulatory standards while fostering innovation in host cell protein (HCP) detection and viral clearance solutions.
Marshall's skills in analytical chemistry, method development, and validation are complemented by his experience in manufacturing transfer and sustaining processes. He is adept at utilizing quality metrics and audits to drive continuous improvement initiatives, ensuring that the products developed not only meet but exceed industry standards. His commitment to quality and safety in biotherapeutics positions him as a key player in advancing the capabilities of Cygnus Technologies and enhancing the overall integrity of the biopharmaceutical landscape.
