Tissue Operations Manager

Há 2 dias

Curitiba, Paraná, Brasil beBeeSkills Tempo inteiro R$45.000 - R$130.000
Job Title:

Manager - Tissue Operations

Job Description:

We are seeking a highly skilled and experienced professional to manage 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 designated regions, requiring management of contract employees. The ideal candidate will have experience in Apheresis Operations Management, QA Operations, GMP production, GTP or other relevant operational areas.

The Manager - Tissue Operations will be responsible for 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 the 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, communicating collection site on-boarding status to Clinical teams and developing and executing mitigation plans for any delayed timelines, performing technical site assessments and train collection center staff on collection requirements and attend site audits as required, providing Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centers, managing rollout of process changes to assigned sites, collecting VOC (voice of customer) and VOB (voice of business) feedback used for continuous operations improvement, collecting and entering data into electronic data management systems, representing the department on cross-functional project teams as requested and complying with applicable SOP's and regulations.

Requirements:
  • Experience in Apheresis Operations Management, QA Operations, GMP production, GTP or other relevant operational areas
  • Breadth of experience in regulated environment, understanding of HTA
  • Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs
  • Experience working with critical raw material suppliers or contract manufacturing organizations
  • Has successfully worked in a team-based environment
  • Ability to rapidly solve problems and deal with organizational complexity
  • Ability to prioritize and complete work with sense of urgency based on criticality
Qualifications:
  • Undergraduate degree in related science or nursing
  • Advanced degree in related science or nursing preferred
  • Be fluent in English and Portuguese
Benefits:
  • Rapidly solving complex problems in an organizational setting
  • Working in a team-based environment with a focus on collaboration and communication
  • Managing multiple tasks and projects simultaneously with high attention to detail and organization skills
  • Ensuring compliance with regulatory requirements and company policies
Others:

As a key member of our team, you will be expected to demonstrate excellent interpersonal and presentation skills to communicate effectively across all levels within the organization and multiple cultures, while considering the impacts of decisions on the customer (treatment centre), striving to ensure that process changes improve and do not impede customer service when possible, while ensuring compliance with regulations.

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