This role is to define and lead the establishment & implementation of requirements for leukapheresis (apheresis) collection globally. With the launch of cell therapy, different technical & regulatory requirements plague countries & regions around the globe. This leader will be required to align to global requirements for collection (collection, labeling, and support in shipping), training for the sites, and supporting local regulatory concerns as highlighted.
Set up of regional cryopreservation sites, establishment of this process, and ensuring that we are providing the best starting material for manufacturing is also key to this role. Alignment across leadership (Quality, Regulatory, Commercial, & within Supply Chain) is critical for this role.
Leadership of a global team with “in region” experts will be required.
Education around requirements, processes, procedures will be critical for success within this role.
Influencing both internal & external stakeholders & regulatory bodies on support with global standards, material classification, and functional requirements for the process, is a must.
Define, then standardize Global Requirements for Apheresis Collection. Review & Align with Regional / Country Partners to ensure compliance with local regulations.
Develop Training Parameters for Training & Onboarding of Cryopreservation Sites globally
Define Strategy for Local vs. Central Cryopreservation, support recommendations on contractual terms, as appropriate, for these options. Influence locally to implement.
Support Execution of Apheresis / Cryopreservation with local team partners to support meeting country patient demand.
Triage & Support issues related to patient apheresis collection & cryopreservation.
Maintain Leadership in Patient Apheresis Collection through attendance at conferences, writing papers, etc.
Child care benefits
Short term disability