Director of Operations for CAR T-cell Therapies

Há 2 dias

Porto Alegre, Brasil beBeeManagement Tempo inteiro
Senior Manager - Tissue Operations

This role serves as a technical operations single point of contact for designated regions and may require contract employee management.

The Senior Manager manages onboarding and performance of Apheresis and Treatment Centres for CAR T-cell Therapies. This role is remotely based to service designated regions with up to 75% regional travel required.

Key Responsibilities:

  • Develop relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned region.
  • Work with Clinical and Commercial CAR-T teams to establish apheresis collection footprint for assigned region.
  • Coordinate with internal teams and collection site staff to ensure successful collection site onboarding activities within required timelines.
  • Communicate collection site on-boarding status to Clinical teams and develop mitigation plans for delayed timelines.
  • Perform technical site assessments and train collection center staff on collection requirements.
  • Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centers.
  • Manage rollout of process changes to assigned sites. Collect VOC and VOB feedback for continuous operations improvement.
  • Represent the department on cross-functional project teams.
  • Comply with applicable SOP's and regulations.

Demonstrated skills and competencies:

E – Essential

P – Preferred

Experience:

  • Experience in Apheresis Operations Management, QA Operations, GMP production or other relevant operational areas (E)
  • Regulated environment experience and understanding of HTA (E)
  • Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs (P)
  • Experience working with critical raw material suppliers or contract manufacturing organizations (E)
  • Operational experience for supplier qualification and management of external Apheresis, Cellular Therapy or Stem Cell Transplant programs (P)
  • Team-based environment experience (E)
  • Process improvements experience, preferably in qualification, training and management of external cell procurement suppliers (E)
  • Contract management experience with external apheresis providers (P)
  • Customer-facing role in pharmaceutical/biotech industry (P)

Qualifications:

  • Undergraduate degree in related science or nursing (E)
  • Advanced degree in related science or nursing (P)
  • Fluency in English and Portuguese (E)

Skills/Specialist knowledge:

  • Rapid problem-solving and organizational complexity management
  • Ability to prioritize work with sense of urgency
  • Medical, scientific and clinical knowledge
  • Knowledge of applicable regulations and standards
  • High attention to detail skills
  • Organization skills with ability to multi-task several tasks in parallel
  • Customer-centricity and interpersonal/presentation skills

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