Tissue Operations Manager

Há 3 dias

São Paulo, São Paulo, Brasil beBeeSenior Tempo inteiro R$72.000 - R$96.000

Job Summary:

The Manager, Tissue Operations role is accountable for managing onboarding and ongoing performance of Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies.

This position will serve as the technical operations single point of contact for Apheresis and Treatment Centres located within the designated region and may require management of contract employees.

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

Key Responsibilities
  1. Develop and foster relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned region.
  2. Work with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint to support the clinical trial site plans for assigned region.
  3. 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.
  4. Communicate collection site on-boarding status to Clinical teams and develop and execute mitigation plans for any delayed timelines.
  5. Perform technical site assessments and train collection center staff on collection requirements and attend site audits as required.
  6. Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centers.
  7. Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch.
  8. Manage rollout of process changes to assigned sites.
  9. Collect VOC (voice of customer) and VOB (voice of business) feedback used for continuous operations improvement.
  10. Collect and enter data into electronic data management systems.
  11. Represent the department on cross-functional project teams, as requested.
  12. Comply with applicable SOP's and regulations.
Required Skills and Qualifications
  • 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).
  • Experience working with critical raw material suppliers or contract manufacturing organizations.
  • 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.
Benefits

This role offers the opportunity to work in a dynamic and growing industry, with a focus on developing and implementing innovative solutions to improve patient outcomes.

Others

This is an exciting opportunity for a motivated and experienced professional to join our team and contribute to the success of our organization.

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