Senior Lead

4 semanas atrás

Manaus, Amazonas, Brasil beBeeOperations Tempo inteiro

Job Overview

We are seeking a seasoned professional to lead the onboarding and performance of Apheresis and Treatment Centres for CAR T-cell Therapies. This key role will serve as the technical operations single point of contact for assigned regions, overseeing all aspects of site readiness and collection centre staff training.

Key Responsibilities:

  • Develop strong relationships with Apheresis, Cell Lab, and Treatment Centre staff for assigned regions, fostering effective collaboration and communication.
  • Work closely with Clinical and Commercial CAR-T teams to establish apheresis collection footprints for clinical trial site plans, ensuring seamless execution and timely completion.
  • Coordinate onboarding activities with internal teams and collection sites, ensuring timely completion and site readiness.
  • Communicate collection site status to Clinical teams and develop mitigation plans for delayed timelines, demonstrating proactive problem-solving skills.
  • Perform site assessments, train collection centre staff, and participate in audits and deviation activities, upholding the highest standards of quality.
  • Collaborate with Quality Assurance to monitor vendor performance and capacity after site launch, identifying areas for improvement and implementing process changes as needed.
  • Represent the department on cross-functional project teams, contributing valuable insights and expertise to drive business success.
  • Comply with applicable SOPs and regulations, ensuring adherence to industry standards and best practices.

Demonstrated Skills and Competencies:

E – Essential P – Preferred

  • Experience in Apheresis Operations Management, QA Operations, GMP production, or other relevant areas (E)
  • Breadth of experience in regulated environments, understanding of HTA (hospital or pharmaceutical/biopharmaceutical company) (E)
  • Experience working in Apheresis, Cellular Therapy, or Stem Cell Transplant programs (P)
  • Successful teamwork experience (E)
  • Delivered process improvements in qualification, training, and management of external suppliers (E)
  • Managed contracts with external apheresis providers (P)
  • Prior customer-facing roles in pharmaceutical/biotech industries (P)

Qualifications:

  • Undergraduate degree in related sciences or nursing (E)
  • Advanced degree in related sciences or nursing (P)
  • Fluent in English and Portuguese (E)

About the Role:

The ideal candidate will possess a unique blend of technical expertise, leadership skills, and business acumen. If you are a results-driven professional with a passion for driving excellence in Apheresis Operations, we encourage you to apply for this exciting opportunity.

What We Offer:

This is an exceptional opportunity to join a dynamic team of professionals who share your passion for delivering high-quality services. As a valued member of our organization, you can expect a challenging and rewarding work environment that fosters growth, learning, and innovation.

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