Upstate Stem Cell cGMP Facility

Meet the Team

Michael FiskeMichael J. Fiske, M.S.
Executive Director
Upstate Stem Cell cGMP Facility
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Mike has more than a decade of clinical-scale cGMP experience as the former Manager of GMP Production and Analytical Services at Wyeth Vaccines and Director of GMP Clinical Production for Genencor International. He has experience with facility start-up activities including facility, utilities, and equipment validation, as well as the development and implementation of a GMP compliant Quality System. In addition, Mike has significant experience managing technology transfer, GMP process development, analytical method development and validation, as well as interactions with regulatory agencies.
 

For more information, or to inquire about the availability of the GMP facility for research, please contact Michael J. Fiske.

 

Caitlin Brown

Caitlin Brown
Associate Scientist, cGMP Process/Analytical Development
Upstate Stem Cell cGMP Facility
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Caitlin provides support to the quality assurance program here at the Upstate Stem Cell cGMP Facility, by managing the environmental monitoring program, employee training, raw material and product receiving and release, as well as document control. She is also involved with GMP production, and GMP process/analytical development. Caitlin graduated from the University at Buffalo with a BS in Biotechnology. Her previous positions included Research Analyst at Duke University in the Laboratory for AIDS Vaccine Research & Development where she worked in a GLP environment and as a Lab Technician in the department Microbiology and Immunology here at the University of Rochester.

 

 


Megan GrangerMegan Granger
Associate Scientist, Development and Manufacturing
Upstate Stem Cell cGMP Facility
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Megan is a key component of the GMP production team here at the Upstate Cell cGMP Facility, responsible for the process / analytical development and manufacturing of GMP materials in the facility. She has always had a passion for science and technology, starting in high school she participated in the RIT partnered ASCENT program for the advanced study of engineering, but ultimately found her niche in the biotechnology program at Buffalo State College. Following graduation, Megan got her first taste of pharmaceutical research and GMPs working for the vision care R&D group at Bausch + Lomb. Since then she has gone on to manage an HIV research lab here at the University of Rochester, responsible for the safety and training of 20+ students, postdocs, and technicians. She joined the USCGF team in 2013. 


 

Karen HarringtonKaren Harrington

Associate Scientist cGMP Prpcess/Analytical Development
Upstate Stem Cell cGMP Facility
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Karen is a recent addition to the USCGF staff coming to us after 9 years at Bausch and Lomb in Nonclinical Safety and Preclinical Pharmacology. She graduated with a BS in Biology from Widener University and has over 10 years of experience in cell culture and in vitro cell-based assays. In addition, Karen previously worked as a Laboratory Technician at the University of Rochester in the Environmental Medicine department. Karen’s current responsibilities at the USCGF include collaboration with contract research clients in technology transfer, cell culture process development, analytical methods development and qualification as well as manufacturing of GMP clinical trial materials and QC release testing.


 
 

Christine Sanfilippo

Associate Scientist cGMP Process/Analytical Development
Upstate Stem Cell cGMP Facility
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Sharyl ZaccaglinoSharyl Zaccaglino
Director, Research Quality and Compliance
Upstate Stem Cell cGMP Facility
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As Quality and Compliance Director for the URMC, Sharyl is responsible for establishing and maintaining the Quality System for the Upstate Stem Cell cGMP Facility and ensuring compliance to its approved procedures. She comes to the university with more than 15 years of quality and compliance experience in the biotechnology and medical device industries. She held the position of Quality Manager at Genencor International, where she was responsible for implementing the GMP-compliant quality system. More recently, she was the Quality System Manager at Ortho Clinical Diagnostics, building robust quality processes and ensuring sustained compliance to the Quality System Regulation in R&D.