* Joint PhD in Engineering and Medical
Science with a strong technical
background in biochemical engineering,
manufacturing process development,
analytical test development, molecular
biology, and biochemistry. * Over 20
years combined industry experience in
a scientific leadership role as a VP/
Senior Director/ Global Director/Head
in Research and Development in both
small biotech and large biopharma
environments. * Broad experience in
different aspects of vaccine and
therapeutic development including
mRNA-LNP, subunit and live viral
vaccines, mAbs, animal cell culture,
antibody technology, diagnostics,
recombinant protein expression and
purification, molecular biology,
Piggybac transposon technology,
baculovirus-insect cell culture,
bacterial expression, virology,
bioreactor operation and scale-up,
assay development, product formulation
and stability, bioinformatics, and
proteomics. * Strong understanding of
CMC regulatory requirements for
vaccines and therapeutics and authored
numerous strategy documents
(manufacturing, analytical,
impurities, troubleshooting), journal
publications, risk assessments for
different CMC elements, QBD
approaches, comparability reports,
technical documents, prepared entire
CMC DS and DP sections for regulatory
submissions (IND, FDA, CTD) as well as
IB contributions and briefing
packages. * Considerable experience in
technology transfer and outsourcing of
material manufacture by CDMOs (live
virus, mRNA, LNP, plasmid, recombinant
protein, antibodies, virus, diagnostic
kit manufacture), process validation,
and corresponding analytical test
development and QC. * Five years as a
university academic with collaborators
in cancer research, infectious
diseases, parasitology, and
engineering. Developed DNA-protein
expression vectors using transformed
cells and licensed to Life
Technologies