development team in our cell and gene therapy organization. This position is expected to provide key technical leadership in... degree) and 15+ years of relevant employment experience Experience in CMC analytical development of gene & cell therapies...
and Gene Therapy manufacturing internal operations across all phases of development and commercial, support of analytical... and compliance. Knowledge of aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing...
, including IND activity, global CTAs, DSURs and Agency briefing documents in US and ex-US. Experience in gene therapy, cell...MUST HAVES: AAV Gene Therapy Experience Key Duties & Accountabilities: Actively represent Regulatory CMC...
for distribution, logistics, and warehousing for complex supply chains involving small molecule, biologics and Cell and Gene Therapy...) Strong understanding of Cell & Genetic therapy cold chains. Supply Chain professional with Six Sigma certification desired, including...