The Director/Senior Director CMC Analytical Validation is responsible for method transfers; method improvement; method remediation and method validation/verification and/or troubleshooting for late stage clinical products within the Quality Control laboratories. S/he manages both external CMOs and CROs in the cell and gene therapy space, including but not limited to, Drug Product (DP) release testing and characterization. In cooperation CMOs and CROs, S/he is responsible for planning, reviewing and approving analytical method qualifications and validation preBLA at all CMOs and CROs. S/he will be highly interactive and function at a high level in a matrix management environment that includes, but may not be limited to, Analytical Development, Process Development, Clinical and Commercial Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Supply Chain, and Discovery Research. The Director/Senior Director CMC Analytical Validation ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.