Cellular Therapies Manager

Há 3 horas

Manaus, Brasil Caderno Nacional Tempo inteiro

Segmento

Segmento: Não Informado

Atividades
  • The successful candidate will be responsible for developing and fostering relationships with Apheresis, Cell Lab, and Treatment Centre Staff.
  • The Tissue Operations Manager will work closely with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint.
  • This will involve coordinating onboarding activities for collection sites and ensuring they are prepared to perform collections within required timelines.
  • The manager will communicate on-boarding status and develop mitigation plans for delayed timelines.
  • They will also perform technical site assessments, train staff, and attend site audits as required.
  • In addition, the Tissue Operations Manager will provide Quality Systems support by participating in deviation activities and impact/investigation assessments.
  • They will monitor and assess vendor performance and capacity after site launch.
  • The manager will manage rollout of process changes to assigned sites and collect VOC and VOB feedback for continuous operations improvement.
  • They will also collect and enter data into electronic data management systems.
  • As a representative of the department, the Tissue Operations Manager will participate in cross-functional project teams and comply with applicable SOPs and regulations.
Requisitos e Qualificações
  • Apheresis Operations Management experience (essential)
  • Regulated environment experience, understanding of HTA (essential)
  • Apheresis, Cellular Therapy or Stem Cell Transplant programs experience (preferred)
  • Critical raw material suppliers or contract manufacturing organizations experience (essential)
  • Operational role experience for supplier qualification and management of external Apheresis, Cellular Therapy or Stem Cell Transplant programs (preferred)
  • Team-based environment experience (essential)
  • Process improvements experience, ideally in processes for qualification, training, and management of external cell procurement suppliers (essential)
  • Managing contracts with external apheresis providers experience (preferred)
  • Customer facing role experience in pharmaceutical/biotech industry (preferred)
  • Qualifications: Undergraduate degree in related science or nursing (essential)
  • Advanced degree in related science or nursing (preferred)
  • Fluent in English and Portuguese (essential)
  • Skills/Specialist knowledge: Rapid problem solving and organizational complexity
  • Prioritizing and completing work with sense of urgency
  • Medical, scientific and clinical knowledge
  • Applicable regulations and standards
  • Attention to detail skills
  • Organization skills with ability to multi-task
  • Customer-centricity
  • Consider the impacts of decisions on the customer (treatment centre)
  • Interpersonal and presentation skills
Observações Adicionais

Dias da Semana: Não Informado

Horário / Período: Não Informado

Os interessados devem se candidatar através do portal Caderno Nacional

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