General Manager II managing a complex QSR or Casual Dine Restaurant for HMSHost. Ensuring operational and financial success while leading and training staff in restaurant standards.
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
Requirements
- 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)
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- pension plan
- 401(k) savings plan
- annual performance bonus
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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