Tissue Operations Manager

3 semanas atrás

Brasil beBeeOperations Tempo inteiro
Job Description

The Manager - Tissue Operations is 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 the designated region, requiring management of contract employees.

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

  • Develop and foster relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned region.
  • Work with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint to support the clinical trial site plans for assigned region.
  • 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 the required timelines.
  • Communicate collection site on-boarding status to Clinical teams and develop and execute mitigation plans for any delayed timelines.
  • Perform technical site assessments and train collection center 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 centers.
  • 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 the department on cross-functional project teams, as requested.
  • Comply with applicable SOP's and regulations.
Required Skills and Qualifications

Essential:

  • Experience in Apheresis Operations Management, QA Operations, GMP production, GTP or other relevant operational areas.
  • Breadth of experience in regulated (GxP) environment, understanding of HTA (either hospital or pharmaceutical/biopharmaceutical company).
  • Has successfully worked in a team-based environment.
  • Experience in delivering process improvements, ideally in processes for qualification, training, and management of external cell procurement (Apheresis) suppliers.
  • Undergraduate degree in related science or nursing.
  • Be fluent in English and Portuguese.

Preferred:

  • Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs.
  • Experience working with critical raw material suppliers or contract manufacturing organizations.
  • Experience in an operational role for supplier qualification and management of external Apheresis, Cellular Therapy or Stem Cell Transplant programs.
  • Experience managing contracts with external apheresis providers.
  • Prior customer facing role in pharmaceutical/biotech industry.
  • Advanced degree in related science or nursing.
Benefits

This role offers a chance to work in a dynamic and growing industry, with opportunities for professional growth and development.

Others

As a remote worker, you will have the flexibility to work from anywhere, while still being part of a collaborative and supportive team.

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