Sandra Lueken
About Sandra Lueken
Sandra Lueken serves as the Vice President of Quality Operations at StrideBio, Inc., bringing over 20 years of experience in the pharmaceutical industry. Her background includes significant roles at MedImmune, Baxter Healthcare, and AstraZeneca, where she contributed to various aspects of drug manufacturing and quality assurance.
Current Role at StrideBio
Sandra Lueken serves as the Vice President of Quality Operations at StrideBio, Inc., a position she has held since 2021. Located in Research Triangle Park, NC, she oversees quality operations, ensuring compliance with regulatory standards and maintaining high-quality manufacturing processes. Her role involves managing quality systems and processes that support the development and production of innovative therapies.
Previous Experience at MedImmune
Prior to her current role, Sandra worked at MedImmune as Senior Director of Quality FMC from 2013 to 2016. In this capacity, she was responsible for quality management and oversight of manufacturing processes, contributing to the development of biologic products. Her experience at MedImmune helped her build a strong foundation in quality assurance within the biopharmaceutical industry.
Professional Background in Quality Operations
Sandra has over 20 years of experience in the biopharmaceutical industry, with a comprehensive skill set covering the entire drug manufacturing lifecycle. Her expertise includes research and development, assay development, tech transfer, scale-up activities, and global regulatory filing. She has held significant positions at various companies, including Baxter Healthcare and KBI Biopharma, where she advanced quality operations and compliance initiatives.
Educational Qualifications
Sandra earned her MBA from the University of Arizona - Eller College of Management, completing her studies from 1999 to 2001. She also holds a Bachelor's degree in Biochemistry from the University of Arizona, which she obtained from 1994 to 1996. Her educational background provides her with a solid foundation in both business management and scientific principles.
Regulatory and Quality Achievements
Throughout her career, Sandra has supported filing reviews and inspections for four Biologics approvals between 2014 and 2018. Her roles have included significant responsibilities in quality assurance and compliance, ensuring that products meet regulatory standards from pre-clinical stages through to commercial approval. This experience reflects her capability in navigating complex regulatory environments.