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Sarah Madonna

Sr Dir Of GMP Operations (ivp) at Kiromic Biopharma

Sarah Madonna has a diverse work experience in the biopharmaceutical industry. Their most recent role was as the Senior Director of GMP Operations at Kiromic Biopharma, Inc., where they led and supported T-cell manufacturing, supply chain, and QC EM teams. Sarah reported all activities and timelines to the COO. Prior to this, Sarah held positions such as Senior Director of Manufacturing Operations, Director of Manufacturing (Operations), and GMP Manager at Kiromic Biopharma, Inc., where they oversaw cellular and viral manufacturing, supply chain, and performed various duties including GMP build-out, equipment purchase, and compliance with regulations.

Before joining Kiromic Biopharma, Inc., Sarah worked as a GMP Specialist at Houston Methodist and as a Lead RAII for process development and validations at InGeneron. Sarah also worked as a Lead GMP RAII at Rejenive Therapeutics, where they were responsible for GMP retrofit build-out, QC lab activities, SOPs, equipment maintenance, and GMP flow.

Earlier in their career, Sarah worked as a QC Manager at Celltex Therapeutics Corporation, where they managed QC personnel, performed final product release testing, and implemented an EM program. Sarah also held roles at Bellicum Pharmaceuticals, Inc., MD Anderson Cancer Center, University of Miami Miller School of Medicine, University of Miami, and AstraZeneca R&D.

Overall, Sarah Madonna has extensive experience in GMP operations, manufacturing, process development, quality control, and laboratory management within the biopharmaceutical industry.

Sarah Madonna obtained a Bachelor of Science (BS) degree in Biology with a pre-med/vet focus from Shippensburg University of Pennsylvania, where they attended from 2001 to 2005. Sarah then pursued a Master of Science (MS) degree in Biology with an emphasis on pathogenetic parasitology at the same university, completing their studies from 2005 to 2008. In addition to their academic achievements, Sarah has obtained multiple certifications in areas such as Basic Export Control, Biomedical Responsible Conduct of Research, Conflict of Interest, Dual Use Research of Concern (DURC), Financial Issues in Research, Group 1 - Biomedical, Group 5 - GCP Good Clinical Practice, Human Subjects Biosafety, Laboratory Access, and Shipping and Transport of Regulated Biological Materials, mostly from the CITI Program. The most recent certification they obtained was "Shipping and Transport of Regulated Biological Materials" in September 2022.

Links

Previous companies

Houston Methodist logo
InGeneron logo

Timeline

  • Sr Dir Of GMP Operations (ivp)

    May 1, 2023 - present

  • Senior Director of Manufacturing Operations

    June, 2022

  • Director Of Manufacturing (operations)

    March, 2022

  • GMP Manager

    June, 2021