Senior Manager of Regulated Cellular Therapies

Há 2 dias

Rio de Janeiro, Rio de Janeiro, Brasil beBeeManager Tempo inteiro R$90.000 - R$120.000
Job Description:

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

This role 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.

The ideal candidate will have experience in Apheresis Operations Management, QA Operations, GMP production, GTP or other relevant operational areas and a breadth of experience in regulated (GxP) environments.

Responsibilities include developing and fostering relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned region, working with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint to support clinical trial site plans for assigned region, coordinating 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.

Key Responsibilities:
  • 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 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 required timelines.
  • Communicate collection site onboarding 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.
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