Senior Biopharmaceutical Operations Coordinator

Há 4 dias

Brasil beBeeOperations Tempo inteiro R$1.837.500 - R$2.155.000
Biopharmaceutical Operations Specialist

We are seeking a skilled Biopharmaceutical Operations Specialist to oversee the onboarding and 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 within designated regions, involving contract employee management and collaboration with Clinical and Commercial CAR-T teams.

Key Responsibilities:
  • Develop relationships with Apheresis, Cell Lab, and Treatment Centre Staff for assigned regions.
  • Collaborate 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 onboarding activities and sites are prepared for collections within required timelines.
  • Communicate collection site onboarding status to Clinical teams and develop mitigation plans for delayed timelines.
  • Conduct technical site assessments, train collection centre staff on collection requirements, and attend site audits as necessary. Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centres.
  • Work with Quality Assurance and other business partners to monitor and assess vendor performance and capacity after site launch.
  • Manage process changes rollout 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 SOPs and regulations.
Required Skills and Qualifications:
  • Undergraduate degree in a related science or nursing field.
  • Advanced degree in a related science or nursing field preferred.
  • Fluency in English and Portuguese.
  • Experience in Apheresis Operations Management, QA Operations, GMP production, GTP, or other relevant operational areas.
  • Breadth of experience in regulated environments, understanding of HTA.
Benefits:

This role offers a unique opportunity to work remotely and travel up to 75% of the time, serving designated regions. The position requires excellent interpersonal and presentation skills for effective communication across levels and cultures.

The ideal candidate will possess rapid problem-solving and organisational complexity management skills, prioritisation and completion of work with urgency based on criticality, and high attention to detail skills.

Others:

Successful candidates will demonstrate medical, scientific, and clinical knowledge, as well as knowledge of applicable regulations and standards.

They will also be able to manage process changes rollout to assigned sites, collect VOC and VOB feedback for continuous operations improvement, and represent the department on cross-functional project teams as requested.

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