Bachelor of Science degree in Biological Sciences, BiomedicalChemical Engineering, or a related field, or foreign equivalent and 12 years of progressive, postbaccalaureate biotech, cell or gene therapy, or pharmaceutical industry experience. Experience must include 3 years of experience in each of the followingbr Clinical or Commercialscale manufacturing for cell culture, purification, aseptic final product filing andor analytical reagent manufacture;br Working with GMPs and FDA and EMA regulations, including handling at least two health authority regulatory inspections and authoring at least one regulatory submission for site startups or process transfers;br Project management for process development, process scale uptech transfer or process validation scaleup;br Managing cGMP operations in the biotech or pharmaceutical industry;br Supporting facility design and site startup activities; andbr Direct experience working with cell and or gene therapy processesbr br Experience may be gained concurrently.

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