Manager, Global Cell Collection
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Beerse • Belgium
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About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
ImmunologyCell BiologyCell TherapyApheresisCryopreservationGood Tissue Practices (GTP)current Good Manufacturing Practices (cGMP)risk managementchange managementprocess improvement
Soft skills
communication skillsinterpersonal skillsindependent workcross-functional teamworkproblem resolutionflexibilityadaptabilityprioritizationstakeholder engagementcustomer experience