Cellular Therapies Manager

Segmento

Segmento: Não Informado

• 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.

• 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

Dias da Semana: Não Informado

Horário / Período: Não Informado

Os interessados devem se candidatar através do portal Caderno Nacional