Miriam Estrano, M.Sc

Cell Therapy Project Manager

Miriam Estrano holds a Master's of Science in Biology from the University of Memphis, TN, and earned the Regulatory Affairs Certification from the Regulatory Affairs Professionals Society. Miriam was a research assistant in the Department of Biochemistry at the Weizmann Institute of Science and also at Northwestern University in Chicago. She also holds a Bachelor's of Science degree in Biology from the Open University, Tel Aviv.

Miriam has 15 years of broad experience in QARA leadership positions in the USA.  Her regulatory experience encompasses drugs, biologics, cellular therapies, and medical devices, as well as human cells, tissues, and cellular and tissue-based products (HCT/Ps). She has worked in cutting edge biotechnology and medical device industries including Medtronic, TiGenix, Meridian Biosciences, and Baxter Healthcare.

During her management role at Medtronic in the USA Ms. Estrano was the site lead, managed the Quality Management System and hosted many successful FDA inspections. At TiGenix, as Head of QA/QC, Miriam was responsible for setting-up the Belgian company's US cleanroom facility from the ground-up in Memphis, Tennessee. Miriam established the QMS for TiGenix' cellular therapy products, oversaw the validation of the cleanroom facility, led the QC laboratory, and supported product development and technical transfer.

Ms. Estrano contributed to the writing of "Guidance Document: Microbiological Process Validation & Surveillance Program" and the 14th edition Tissue Bank Standards by the American Association of Tissue Banks, was a member of the AATB's Scientific and Technical Affairs Committee and an editorial member of the Parenteral Drug Association (PDA). She has published several articles, including "Challenges in Aseptic Production of Sterile Biologics", published in the PDA Letter. 

Within Miriam's framework at Gsap, she serves as the Cell Therapy Project Manager.