Lead the gene editing process development team and manage the development of mRNA manufacturing platforms for a portfolio of gene therapy and gene editing products
Responsible for mentoring a team of scientists in the laboratory and supporting the design, execution and interpretation of experimental studies
Represent the team at various meeting forums (e.g. CMC, regulatory)
Author/review CMC sections of regulatory filings as needed
Lead process scale up efforts
Review experimental plans for screening, optimization, and scale-up efforts for mRNA production, chromatographic separations and filtration processes including microfiltration, depth filtration, ultrafiltration, diafiltration, and sterile filtration.
Lead technology transfer to manufacturing by performing risk assessments, reviewing development reports, reviewing master batch records for GMP manufacturing, and providing technical suppo