The Director/Senior Director, Cell Process Development will serve as a strategic partner and advisor for the technical staff within the Cell & Gene Therapy - Technical Development organization. This senior role will provide key input to shape both early- and late-stage development strategies for our CAR-T therapies by collaborating closely across a number of functions within the organization including but not restricted to Research/Discovery, Program Management, Clinical Manufacturing, Quality, and Regulatory-CMC! The ideal candidate will have broad expertise in CMC development and compliance, complemented by deep technical expertise in cell processing technology. This role will report to the Global Head of Technical Development for CAR-T programs and will participate and/or lead several cross-functional committees.
Your responsibilities include, but are not limited to: * Experienced leader with deep technical insights that drives key initiatives including trouble-shooting Manufacturing challenges. * Establish metrics and tracking mechanisms to trend processes in terms of performance with clear traceability to source records. * Evaluate and implement automated cell processing technologies with the potential to integrate with automated analytical technologies while drafting the appropriate accompanying documentation for training and consistency. * Active participation with potential to lead cross-functional committees with broad scope. * Establishes forums for information sharing to enable development decision making. * Develops and maintains strong, internal partnerships with cross-functional colleagues. * Authors and reviews technical documents including summary reports and procedures to hand over to internal and/or external partners including source documents for regulatory submissions. * Delivers high impact, technical findings and concepts to senior leaders within the organization.