Tissue Operations Specialist

Há 3 dias

Recife, Pernambuco, Brasil beBeeOperations Tempo inteiro
Job Opportunity

We are seeking a skilled professional to assume the role of Tissue Operations Manager. This position will be responsible for overseeing the onboarding and ongoing performance of Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies.

This role will serve as the technical operations single point of contact for Apheresis and Treatment Centres located within the designated region, managing contract employees and requiring regional travel up to 75% of time.

  • Develop and foster relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned region.
  • Work with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint to support the clinical trial site plans for assigned region.
  • Coordinate with internal teams and collection site staff to ensure all collection site onboarding activities are successfully completed and sites are prepared to perform collections within the required timelines.
  • Communicate collection site on-boarding status to Clinical teams and develop and execute mitigation plans for any delayed timelines.
  • Perform technical site assessments and train collection center staff on collection requirements and attend site audits as required
  • Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centers.
  • 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 used 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.
Required Skills and Qualifications

To be successful in this role, you will need:

  • A Bachelor's degree in a related science or nursing field.
  • Experience in Apheresis Operations Management, QA Operations, GMP production, GTP or other relevant operational areas.
  • Breadth of experience in regulated environments, understanding of HTA (either hospital or pharmaceutical/biopharmaceutical company).
  • Excellent communication and interpersonal skills, with the ability to work effectively across cultures and levels.
What We Offer

As a valued member of our team, you can expect:

  • A dynamic and supportive work environment.
  • The opportunity to contribute to cutting-edge research and development initiatives.
  • A competitive salary and benefits package.
About Us

We are a leading biopharmaceutical company dedicated to developing innovative treatments for cancer. Our team is passionate about making a difference in people's lives and we strive to create a positive impact through our work.

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