About the role

CAR-T Cell Collection Manager coordinating activities for EMEA cell therapy initiatives. Ensuring quality and consistency in CAR-T commercial supply chain operations across multiple countries.

Responsibilities

Manage and maintain commercial CAR-T apheresis and cryopreservation activities in support of 2500-3000 CAR-T patient commercial supply chain activities
Serve as primary POC for apheresis center, cryopreservation centers
Serve as apheresis and cryopreservation Subject Matter Authority for internal and external teams
Facilitate and conduct site qualification and training for collections and/or cryopreservation requirements
Activate site as approved supplier, prior to First Patient In (FPI) date
Ensure timely receipt of recall communications from apheresis centers and evaluate impact to product quality
Ensure timely release of quality fresh/cryopreserved apheresis starting material
Complete quality issues management within 24-48 hours post apheresis
Complete risk and change management
Develop solid understanding of information technology, logistic transport and regulatory requirements affecting collection and cryopreservation of apheresis starting material
Maintain metrics to manage site performance
Work on strategic projects focused on standardization, process improvement, and ameliorating the customer experience
Network with different internal and external stakeholders, collaborate across different geographic regions

Minimum of a Bachelor’s/University or equivalent degree required; focused degree in Nursing, Medical Laboratory Science, or equivalent scientific or engineering field is preferred
Minimum 6 years of relevant work experience
Hands-on experience with Immunology, Cell Biology, Cell Therapy, Apheresis, and/or Cryopreservation
Strong communication and interpersonal skills, with the ability to work independently and in a cross-functional team environment, to effectively support supplier relationship with up to 30 cell collection sites
Ability to engage with internal cell therapy coordinators and, when needed, hospital personnel to communicate specific and technical requirements for apheresis and cell cryopreservation
Proven experience with Good Tissue Practices (GTP) and current Good Manufacturing Practices (cGMP)
Flexibility to adapt to changing situations and ambiguity, to prioritize tasks according to objectives, and provide problem resolution
Requires proficiency in English to communicate effectively and professionally; proficiency in French and/or Italian is preferred
May require ability and flexibility to work on weekends/off hours for patient support, including the ability to accommodate different global time zones (i.e., LATAM, NA, and EMEA)