Regional Apheresis Site Manager

3 semanas atrás

Rio de Janeiro, Brasil beBeeOperations Tempo inteiro

Job Title: Operations Manager

As a key member of our team, you will be responsible for managing the onboarding and ongoing performance of Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies.

This role serves as the technical operations single point of contact for Apheresis and Treatment Centres located within a designated region. You will develop and foster relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned regions.

Key Responsibilities:

  • Develop and implement operational strategies to ensure successful collection site onboarding activities are completed and sites are prepared to perform collections within required timelines.
  • Perform technical site assessments and train collection center staff on collection requirements.
  • Manage the rollout of process changes to assigned sites and monitor vendor performance and capacity after site launch.
  • Collect and enter data into electronic data management systems.
  • Represent the department on cross-functional project teams as requested.

Requirements:

  • Experience in Apheresis Operations Management, QA Operations, GMP production or other relevant operational areas.
  • Regulated Environment: Breadth of experience in regulated environments, understanding of HTA (hospital or pharmaceutical/biopharmaceutical company).
  • Apheresis Experience: Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs.
  • Supplier Qualification: Experience in an operational role for supplier qualification and management of external Apheresis, Cellular Therapy or Stem Cell Transplant programs.
  • Teamwork: Has successfully worked in a team-based environment.
  • Process Improvements: Experience in delivering process improvements, ideally in processes for qualification, training and management of external cell procurement (Apheresis) suppliers.
  • Customer Facing: Prior customer-facing role in pharmaceutical/biotech industry.

Education:

  • Undergraduate Degree: Undergraduate degree in related science or nursing.
  • Advanced Degree: Advanced degree in related science or nursing.
  • Languages: Be fluent in English and Portuguese.

Skills:

  • Problem Solving: Ability to rapidly solve problems and deal with organizational complexity.
  • Prioritization: Ability to prioritize and complete work with sense of urgency based on criticality.
  • Medical Knowledge: Medical, scientific and clinical knowledge.
  • Regulations: Knowledge of applicable regulations and standards.
  • Attention to Detail: High attention to detail skills.
  • Organization: High organization skills with ability to multi-task several tasks in parallel.
  • Communication: Excellent interpersonal and presentation skills to communicate effectively across all levels within the organization and multiple cultures.

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