Remote Tissue Operations Manager

Há 3 dias

Recife, Pernambuco, Brasil beBeeOperations Tempo inteiro R$900.000 - R$1.200.000
Tissue Operations Manager

We are seeking a highly skilled and experienced Tissue Operations Manager to join our team. The successful candidate will be responsible for managing Apheresis and Treatment Centres used for CAR-T-cell Therapies. This role serves as the technical operations single point of contact for designated regions and may require contract employee management.

This position is based remotely to service designated regions. Up to 75% regional travel may be required.

Key Responsibilities:
  • Develop relationships with Apheresis, Cell Lab, and Treatment Centre Staff for assigned region.
  • Collaborate with Clinical and Commercial CAR-T teams to establish apheresis collection footprint for clinical trial site plans.
  • Coordinate onboarding activities with internal teams and collection site staff to ensure successful completion and sites are prepared within timelines.
  • Communicate onboarding status to Clinical teams and develop mitigation plans for delayed timelines.
  • Perform technical site assessments and train centre staff on collection requirements.
  • Provide Quality Systems support by participating in deviation activities and impact assessments.
  • Monitor vendor performance and capacity after site launch.
  • Manage process changes to assigned sites.
  • Collect VOC and VOB feedback for continuous operations improvement.
  • Represent the department on cross-functional project teams.
  • Comply with applicable SOP's and regulations.
Required Skills and Qualifications:
  • E – Essential
  • P – Preferred
  • Proven experience in Apheresis Operations Management, QA Operations, GMP production or other relevant areas (E)
  • Breadth of experience in regulated environments and HTA understanding (E)
  • Apheresis, Cellular Therapy or Stem Cell Transplant program experience (P)
  • Critical raw material supplier or contract manufacturing organisation experience (E)
  • Supplier qualification and management experience for external Apheresis programmes (P)
  • Team-based environment experience (E)
  • Process improvements experience in processes for qualification, training and management of external suppliers (E)
  • Contract management experience with external apheresis providers (P)
  • Customer-facing pharmaceutical/biotech industry experience (P)
  • Undergraduate degree in related science or nursing (E)
  • Advanced degree in related science or nursing (P)
  • Fluency in English and Portuguese (E)
Benefits:
  • Rapid problem-solving and organisational complexity management
  • Prioritisation and work completion with sense of urgency
  • Medical, scientific and clinical knowledge
  • Knowledge of applicable regulations and standards
  • High attention to detail skills
  • High organisation skills with ability to multitask
  • Customer-centricity and excellent interpersonal presentation skills
Others:
  • This is an exciting opportunity to make a real difference in the lives of patients. If you have the skills and experience we are looking for, please apply now.

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