Operations Manager

Há 5 horas

Criciúma, Santa Catarina, Brasil beBeeDevelopment Tempo inteiro R$90.000 - R$115.000
Job Title:

Senior Manager - Tissue Operations

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This role is responsible for managing the onboarding and ongoing performance of Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies. The Senior Manager will serve as the technical operations single point of contact for Apheresis and Treatment Centres located within the designated region, requiring management of contract employees.

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

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  • 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 SOPs and regulations.
Requirements:
  • 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 (hospital or pharmaceutical/biopharmaceutical company).
  • 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.
  • 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.
  • Experience managing contracts with external apheresis providers.
  • Prior customer facing role in pharmaceutical/biotech industry.
Education and Skills:
  • Undergraduate degree in related science or nursing. Advanced degree in related science or nursing is preferred.
  • Be fluent in English and Portuguese.
Key Skills:
  • Ability to rapidly solve problems and deal with organizational complexity.
  • Ability to prioritize and complete work with sense of urgency based on criticality.
  • Medical, scientific and clinical knowledge.
  • Knowledge of applicable regulations and standards.
  • High attention to detail and strong organizational skills with the ability to multi-task.
  • Customer-centric approach; consider the impact of decisions on the treatment centre while ensuring compliance with regulations.
  • Excellent interpersonal and presentation skills to communicate effectively across all levels within the organization and across cultures.

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