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Director Advanced Therapies, Cell Science

  • Titre Director Advanced Therapies, Cell Science
  • Fonction Operations
  • Sous-fonction Production
  • Lieu Beerse, Antwerp, Belgium; Titusville, New Jersey, United States; Raritan, New Jersey, United States
  • Date de mise en ligne
  • Référence 2306107764W
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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.


Required Minimum Education: Bachelors Degree

Required Years of Related Experience: 10 years

Required Knowledge, Skills and Abilities:

  • (Include any required computer skills, certifications, licenses, languages, etc.)

  • A minimum of a bachelor’s degree in a scientific or engineering discipline is required.

  • An Advanced degree (MS, PhD., Pharm. D., MD, RN) in a scientific discipline is strongly preferred. 

  • A minimum of 8 years of relevant industrial experience is required in a pharmaceutical setting.

  • In depth working knowledge and conversant in GTP, cGMP or GCP is required. 

  • Proficient in regional applicable regulations 

  • Working knowledge and experience with leukapheresis and cell processing is required. 

  • Working knowledge and experience in the treatment of hematologic malignancies including acute leukemias, non-Hodgkins lymphoma and multiple myeloma is preferred. 

  • Stem cell transplant or apheresis eCell therapy development experience and working with health agency established blood/tissue requirements is preferred. 

  • Expertise in evolving health agency regulations regarding cell therapy or gene therapy is preferred.

  • Project Management skills and the ability to interface cross-functionally with clinical personnel is required.

  • Understanding of drug development and submission requirements is preferred. 

  • Manufacturing and logistics understanding/experience is preferred. 

  • Ability to work independently and in a matrixed team environment is required. 

  • Ability to make decisions independently, innovative and strategic thinker with broad vision is required. 

  • Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution is required. 

  • Strong quality mindset is required. 

  • Effective leadership skills and proven ability to foster team productivity and cohesiveness is required. 

  • Proficient in English and at least one additional local language

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