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David Malliaros, Ph.D.

Director, CMC Development & Project Management

Dave has over 30 years of experience in the pharmaceutical, biotechnology and immunodiagnostic industries. He has expertise with several different types of molecules, platforms and programs that include monoclonal antibodies, fusion proteins, AAV gene therapy vectors for rare diseases, peptides, vaccines, and small molecules.

Before joining Syner-G, Dave was employed as an independent consultant. He also assumed positions of increasing responsibilities throughout his career and successfully led small groups and larger departments at companies ranging from start-ups to large organizations.

Dave’s areas of expertise focus on analytical technologies and quality control. He has also worked extensively with CDMOs for over a decade. He understands the complexities and logistical challenges working in the virtual world and is insightful and a problem solver.
He has contributed to various regulatory filings including INDs, BLAs and NDAs focusing on Module 3 of the Common Technical Document.

Dave has published in various journals during his academic and industrial career and has presented at various conferences. He has also taught undergraduate and graduate level courses, most recently at Northeastern University in Boston where he taught a course, Quality Control & Security Validation Issues.

He earned his Ph.D. in Chemistry (Biochemistry concentration) at the University of Lowell. (Now the University of Massachusetts, Lowell) in Lowell, Massachusetts and was a postdoctoral fellow at Harvard University of Public Health/Harvard Medical School in Boston. He received his BS degree from the University of Massachusetts, Amherst.

David Malliaros, Ph.D.'s Recent Articles

Potency Assurance for Cellular and Gene Therapy Products

One of the many challenges around developing cell and gene therapy products is establishing representative potency methods. In 2011, the FDA released the Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products, which supported a phase appropriate approach…

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