Tissue Operations Lead

1 semana atrás

Belo Horizonte, Brasil Caderno Nacional Tempo inteiro

Tissue Operations Lead - Detalhes da Vaga. ? This role will serve as the technical operations single point of contact for Apheresis and Treatment Centres located within a designated region, with potential management of contract employees. ? This position is based remotely to service designated regions, with regional travel up to 75% of time possible. ? Essential Skills: Experience in Apheresis Operations Management, QA Operations, GMP production, GTP or other relevant operational areas Breadth of experience in regulated (GxP) environment, understanding of HTA (either hospital or pharmaceutical/biopharmaceutical company) Ability to rapidly solve problems and deal with organizational complexity Ability to prioritize 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 organization skills with ability to multi-task several tasks in parallel Customer-centricity Consider the impacts of decisions on the customer (treatment centre), striving to ensure that process changes improve and do not impede customer service when possible, while ensuring compliance with regulations Preferred Qualifications: Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs Experience working with critical raw material suppliers or contract manufacturing organizations Experience in an operational role for supplier qualification and management of external Apheresis, Cellular Therapy or Stem Cell Transplant programs Prior customer facing role in pharmaceutical/biotech industry Advanced degree in related science or nursing 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. ? This role offers the opportunity to join our team and contribute to delivering high-quality solutions for clients in the biotechnology and pharmaceutical industries. ? Apply here and Harry Henson will be in touch to discuss your application further. ? . Requisitos para participar do processo. ? . O que oferecemos.

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