Amy Robinson, PhD
Madison,WI
Summary
Dynamic leader with extensive experience developing and leading matrixed cross-functional teams in support of biologics manufacturing efforts.
Recent focus was the startup of a Manufacturing Sciences and Technology team at FUJIFILM Cellular Dynamics The team supports both the GMP and non-GMP manufacturing businesses.
Successfully led process technology transfers from development groups (CDMO and internal) to manufacturing teams Additional key projects were the implementation of an Electronic Batch Record/MES system and an automated cell product vial filler.
These continuous improvement efforts are increasing "right-first-time" manufacturing success, making in-process data capture and analysis more efficient and reducing product contamination events.
Overview
14
14
years of professional experience
Work History
Director, Manufacturing Science and Technology
FUJIFILM Cellular Dyamics
08.2019 - 07.2025
- Developed high-performing MSAT and Lab Services teams by providing mentorship, guidance, and opportunities for professional growth.
- Managed operations and capital equipment budgets effectively to ensure optimal use of resources within the team.
- Established a culture of continuous improvement in cell therapy manufacturing by fostering data driven analysis and decision making.
- Lead technology transfers from both internal development groups and CDMO clients to both GMP and non-GMP manufacturing groups.
- In addition to transferring manufacturing processes, key projects were the successful implementation of an Electronic Batch Record/MES system and an automated cell product vial filler.
- These efforts continue to improve "right-first-time" manufacturing success, in-process data capture and analysis and the reduction of contamination events.
Associate Director, Process Sciences
FUJIFILM Diosynth Biotechnologies
08.2016 - 07.2019
- Developed and led a team of 8 process sciences professionals during the start-up of the CDMO business at the Diosynth Texas site.
- Transferred manufacturing processes from client's or internal process development groups to therapeutics manufacturing. These processes included viral vectored gene therapies and oncolytic viruses (Adeno virus and Adeno Associated Virus) produced from plasmid transfection, HSV, and Baculovirus.
- Guided clients in the selection of clinical phase appropriate raw materials and equipment.
- Assisted in the establishment of automated sterile vial filling equipment.
Principal Scientist
Emergent BioSolutions
05.2011 - 08.2016
- Team member in the buildout and start up of a new manufacturing facility that included controls appropriate for the production of live virus vectors.
- Lead matrixed cross-functional teams in the development and technology transfer of downstream processes for the purification of proteins (recombinant therapeutics and mAbs), and modified Vaccinia virus based vaccines.
- Efforts included the preparation of standard operating procedures and batch records appropriate for the manufacture of early phase therapeutics.
- Assisted in the preparation of CMC sections for regulatory submissions
Education
Ph.D. - Molecular Biology And Biochemistry
University of California, Irvine
Irvine, CABachelor of Science - Biochemistry
University of Wisconsin, Madison
Madison, WICertificate - Biotechnology Project Management
University of Washington
Seattle, WASkills
- Team management and individual mentorship/coaching
- Data driven strategies for continuous improvement in manufacturing operations
- Technology Transfer of cGMP Manufacturing processes
- Implementation of Electronic Batch Record/MES systems
- Implementation of automated aseptic filling equipment
Timeline
Director, Manufacturing Science and Technology
FUJIFILM Cellular Dyamics
08.2019 - 07.2025
Associate Director, Process Sciences
FUJIFILM Diosynth Biotechnologies
08.2016 - 07.2019
Principal Scientist
Emergent BioSolutions
05.2011 - 08.2016
Ph.D. - Molecular Biology And Biochemistry
University of California, Irvine
Bachelor of Science - Biochemistry
University of Wisconsin, Madison
Certificate - Biotechnology Project Management
University of Washington
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