Tissue Operations Specialist

Há 3 dias

São Paulo, São Paulo, Brasil beBeeApheresis Tempo inteiro R$300.000 - R$540.000

Job Opportunity

Apheresis/Tissue Operations Manager: Part Time 1 Year Contract Remote with Travel

We are seeking an experienced Apheresis and Tissue Operations Manager to oversee the onboarding and performance of Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies.

This role is remotely based to service designated regions and may require management of contract employees. Regional travel up to 75% of time may be required.

Key Responsibilities:

  • Foster strong relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned region.
  • Work with Clinical and Commercial CAR-T teams to establish apheresis collection footprint to support clinical trial site plans for assigned region.
  • C 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.
  • Communicate collection site onboarding status to Clinical teams and develop mitigation plans for delayed timelines.
  • Perform technical site assessments and train collection centre staff on collection requirements and attend site audits as required.
  • Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centres.
  • Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch.
  • Manage rollout of process changes to assigned sites.
  • Collect VOC (Voice of Customer) and VOB (Voice of Business) feedback used for continuous operations improvement.
  • Collect and enter data into electronic data management systems.
  • Represent department on cross-functional project teams, as requested.
  • Comply with applicable SOP's and regulations.

Requirements:

  • Strong experience in Apheresis and Tissue Operations Management.
  • Ability to work independently and manage multiple priorities.
  • Excellent communication and relationship-building skills.
  • Experience with quality assurance and regulatory compliance.
  • Proficiency in electronic data management systems.

Benefits:

This is a part-time contract position with remote work options and opportunities for professional growth and development.

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