Tissue Operations Specialist

Há 5 dias

Rio de Janeiro, Rio de Janeiro, Brasil beBeeOperational Tempo inteiro

The Manager - Tissue Operations role requires strategic planning and execution of operational tasks to ensure seamless performance of Apheresis and Treatment Centres for CAR-T cell therapies. The successful candidate will develop and foster relationships with Apheresis, Cell Lab and Treatment Centre Staff while working closely with Clinical and Commercial teams to establish the apheresis collection footprint.

Key Responsibilities:

  • Apheresis and Treatment Centre Onboarding: Coordinate with internal teams and collection site staff to ensure all collection site onboarding activities are successfully completed and sites are prepared to perform collections within required timelines.
  • Collection Site Management: Manage rollout of process changes to assigned sites, collect VOC (voice of customer) and VOB (voice of business) feedback used for continuous operations improvement, and represent the department on cross-functional project teams as requested.
  • Quality Systems Support: Participate in deviation activities and impact/investigation assessments for cell collection centers, work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch.

Requirements:

  • Bachelor's degree in related science or nursing
  • Experience in Apheresis Operations Management, QA Operations, GMP production, GTP or other relevant operational areas
  • Regulated environment experience, understanding of HTA (hospital or pharmaceutical/biopharmaceutical company)
  • Familiarity with applicable regulations and standards

Skills:

  • Problem-solving and organizational skills
  • Medical, scientific and clinical knowledge
  • Customer-centric approach
  • Excellent communication and presentation skills

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