Andrea Hamilton Email and Phone Number

In my spare time I support the local animal rescue centre by performing general house keeping essentials, walking of dogs, playing with the cats and support fundraising and awareness events.

Acquisition of Gyroscope Therapeutics by Novartis. Continued the role from Gyroscope with the addition of Analytical Project Leader to lead the team performing the technical transfer of the analytics for the lead AAV gene therapy from the CDMO into Novartis, in preparation for Phase III and Commercial.More recently refreshing Cell Therapy experience, by supporting OOS investigations as an Analytical Lead.

Created and lead the Quality Control group for multiple AAV gene therapy programs. Worked closely with Analytical Development and Process Development teams to ensure characterization methods were fit for purpose and release assays were validated in preparation for Phase III/Commercial release. Responsible for ensuring release testing at CDMO and CROs were completed timely and compliantly.

Working with the Director of Quality Control to develop and implement the QC strategy for early and late stage AAV gene therapies. Managed outsourced projects, provided scientific scrutiny and interpretation for internal and external QC testing, including data review, trending analysis, compilation of CoAs and contract management.Managed analytical method transfer, method development and validation at CRO and CDMOs.QC lead for the lead product preparing for Phase III and supporting all products in the pipeline ensuring alignment across all products.

Contributed to and participated in the planning, development and implementation of the new cell and gene therapy analytical development team within the development organization.Established the analytical development laboratory and led the team of 5 Scientists to develop release assays, to transfer to QC, and characterization assays for a lentivirus cell therapy. Analytical work stream and matrix team lead for a rare disease asset aligning with plasmid, vector, drug substance and drug product leads to ensure successful product delivery.

Provided consultation for development and validation of analytical methods including nucleic extraction and qPCR, in regulated environments. Supported Business Development activities to expand the NDA Analytics/Envigo Division of CMC Bioassay and Genomics.

o Leadership of a team in CMC Genomics, as part of NDA Analytics, CMC Division and also supporting HLS. o Leading successful development and validation of analytical methods including nucleic extraction and qPCR, in a regulated environment covering pre-clinical studies through to supervising analytical methods for commercial batch release of biological products. o Development of analytical methods has included biological products such as gene and cell therapies, other therapies including oncolytic adenovirus and stem cells.o Experienced in GLP, GCLP and GMP, and Quality Risk Management.o Working within multi-disciplinary and multi-cultural teams, operating with QA, business development, program management as well as direct interaction with global clients and sponsors. o Preparing GLP and GMP documentation including deviation, change control and corrective and preventive action plans as well as data analysis and report production. o Involved in successful MHRA audit with direct involvement with regulators.o Provide technical assistance for nucleic acid based methodologies.o Collaborate with the qPCR group in Barcelona o Member of RQA

o Leadership of multidisciplinary teams in the successful development of assays and instrumentation for a range of Clinical Diagnostic applications.o Management responsibilities included; prioritising work schedules of Scientists, experimental design, problem solving, staff training and mentoring.o Responsible for reviewing project progress and highlighting risks to project leaders.o Contributed to a successful grant application for European Commission Framework 7.o Project manager of a TSB funded grant, which required liaising with Universities and TSB coordinators.o Supported the transfer of a diagnostic consumable to high volume manufacturing.o Contributed to the preparation for ISO 13485 accreditation

o Developed key assays, sample extraction and PCR processes with a number of Government and Private collaborators.o Integrated commercial lab-based processes onto Enigma’s automated platforms. o Established and optimised in-house manufacturing and assembly processes.o Represented the company at National and International conferences.o Contributed to ISO 9001 accreditation

Performed research at the Departments of Infectious Diseases and Paediatrics, which focused on the characterisation of the mechanism by which the clinical pathogen, Group B streptococcus, evades the host immune system.Received the Department of Pediatrics Award of Excellence at the Annual Fellows Research Day, Seattle (April 2005).