Tissue Operations Specialist

Há 2 dias

Goiânia, Goiás, Brasil beBeeOperations Tempo inteiro R$100.000 - R$150.000

Key Responsibilities of Senior Manager - Tissue Operations

  • Develop relationships with Apheresis, Cell Lab, and Treatment Centre Staff for assigned regions.
  • Work with Clinical and Commercial CAR-T teams to establish apheresis collection footprints supporting clinical trial site plans for assigned regions.
  • Coordinate with internal teams and collection site staff to ensure successful collection site onboarding activities and prepare sites for collections within required timelines.
  • Communicate collection site on-boarding status to Clinical teams and develop mitigation plans for delayed timelines.
  • Perform technical site assessments, train collection centre staff on collection requirements, and attend site audits as needed. Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centres.
  • 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 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 SOP's and regulations.
Demonstrated Skills and Competencies:E – Essential:
  • Breadth of experience in regulated environments, understanding of hospital or pharmaceutical/biopharmaceutical company standards.
  • Experience in Apheresis Operations Management, QA Operations, GMP production, GTP, or other relevant operational areas.
  • Has successfully worked in a team-based environment.
  • Experience delivering process improvements, ideally in qualification, training, and management of external cell procurement (Apheresis) suppliers.
  • Prior customer-facing role in pharmaceutical/biotech industry.
P – Preferred:
  • Experience working in Apheresis, Cellular Therapy, or Stem Cell Transplant programs.
  • Experience managing contracts with external apheresis providers.
  • Advanced degree in related science or nursing.
  • Fluency in Portuguese.
Skillset:
  • Ability to rapidly solve problems and deal with organisational complexity.
  • Ability to prioritise 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 skills.
  • High organisation skills with ability to multitask several tasks in parallel.
  • Customer-centricity – consider impacts of decisions on the customer (treatment centre), striving to ensure process changes improve and do not impede customer service when possible, while ensuring compliance with regulations.
  • Excellent interpersonal and presentation skills to communicate effectively across all levels within the organisation and multiple cultures.

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