Paul Gramlich

Executive Director Process Development at Amgen

Cambridge, Massachusetts, United States

About

Experience

  • Amgen (11 yrs)
    • Executive Director, Process Development
      May 2026 - Present · 3 mos

      Effective May 2026 I have relocated to Juncos, Puerto Rico to lead drug substance and attribute sciences process development as Executive Director.

    • Director Process Development
      Sep 2022 - May 2026 · 3 yrs 9 mos

      Since September 2021, I have served as a Pivotal DS Biologics functional area head, first as a Principal Scientist and now as a Director of Process Development. In this role, I lead of team of 37 staff members developing both cell culture and purification biologics processes for a variety of recombinant protein modalities. We support molecules from Phase 1 through BLA filing. Additionally, we support a variety of technology development projects to progress Amgen innovation.

    • Principal Scientist
      Sep 2021 - Sep 2022 · 1 yr 1 mo

  • Graduate Research Assistant at Johns Hopkins University
    Aug 2010 - May 2015 · 4 yrs 10 mos

    My graduate research has been focused on engineering neuron-targeted recombinant proteins. To achieve this goal I have :1) developed novel neuron-specific protein delivery vectors to improve binding and internalization of cargo proteins by neuronal cell types and 2) utilized a variety of receptor-dependent and independent delivery domains to facilitate cargo protein binding and internalization. The majority of my recent work has focused on the development of a neuron-targeted recombinant glucocerebrosidase for neuronopathic Gaucher's Disease therapy. This goal was achieved recently through combination of design, production, and purification optimization.

  • Assistant Scientist, Bioprocess Development at Merck
    Oct 2006 - Aug 2010 · 3 yrs 11 mos

    The four years I spent as a bioprocess development scientist at Merck (formerly Schering-Plough Corporation) provided me with invaluable industry research experience. The focus of my research was mammalian cell culture although some projects were bacterial culture based. My responsibilities included: 1) screening clones for production potential to advance high-priority program projects, 2) the development of new production processes for recombinant proteins,3) assessing the stability of commercial cell lines, and 4) supporting production and medium development efforts by running and managing the Hitachi Amino Acid Analyzer. While the majority of my research was small-scale development I gained a great deal of experience in cell culture scale-up, running up to 500L batches in both bioreactors and wave bioreactors.

  • Biological Lab Technician at Fox Chase Cancer Center
    Jun 2005 - Jul 2006 · 1 yr 2 mos

    In my 13 months as a lab technician with the Seeger Lab at Fox Chase Cancer Center I gained extensive molecular biology experience. Specifically I was responsible for subcloning viral vectors to support Seeger Lab Hepatitis C and West Nile Virus research. Additionally, I gained my first experience in mammalian cell culture at Fox Chase passaging a number of mammalian cell lines. Finally, I managed an independent research project investigating the function of HCV protein NS3 through site-directed mutagenesis.