Monika Cassani
About Monika Cassani
Monika Cassani is an Associate Director of Quality Assurance at Aimmune Therapeutics, with extensive experience in quality oversight across various biopharmaceutical companies. She has held key positions at organizations such as GRAIL, Inc., Genentech, and Amgen, and possesses a strong background in Good Manufacturing Practices and auditing compliance.
Current Role at Aimmune Therapeutics
Monika Cassani serves as the Associate Director of Quality Assurance at Aimmune Therapeutics, a role she has held since 2021. In this position, she is responsible for ensuring quality oversight and compliance within the organization. Her expertise in quality assurance is crucial for maintaining the standards required in the biopharmaceutical industry.
Previous Experience in Quality Assurance
Cassani has extensive experience in quality assurance across various organizations. She worked at GRAIL, Inc. as Associate Director of Quality Systems Audit for four months in 2020. Prior to that, she held positions at Orchard Therapeutics and Genentech, where she served as Senior Manager/AD QA and Senior Technical Manager, QA, respectively. Her career also includes roles at Immunex, Amgen, and Vertex Pharmaceuticals, contributing to her comprehensive understanding of quality systems.
Education and Certifications
Monika Cassani earned a Bachelor of Science in Chemistry from the University of Minnesota-Twin Cities, completing her studies from 1993 to 1997. She also obtained an Associate of Arts degree in English from Minneapolis Community and Technical College. In 2017, she achieved Lean Greenbelt Certification from Lean Sensei International, further enhancing her qualifications in quality management.
Expertise in Quality Oversight
Cassani possesses in-depth knowledge of current Good Manufacturing Practices (cGMPs) applicable to the biopharmaceutical, medical device, and environmental analytical regulatory industries. She has a proven track record in quality oversight of global Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs), particularly in the manufacture of small molecules and cell and gene therapies.
Achievements in Quality Projects
Throughout her career, Monika Cassani has been recognized for her ability to drive accelerated timelines in quality oversight projects. Her expertise in auditing global compliance of CMOs, suppliers, and testing facilities has contributed to the successful implementation of quality assurance measures across various organizations.