Director Of Operations For Car T-Cell Therapies
Há 3 dias
Senior Manager - Tissue OperationsThis 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 – PreferredExperience: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 managementAbility to prioritize work with sense of urgencyMedical, scientific and clinical knowledgeKnowledge of applicable regulations and standardsHigh attention to detail skillsOrganization skills with ability to multi-task several tasks in parallelCustomer-centricity and interpersonal/presentation skills
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Porto Alegre, Brasil beBeeManagement Tempo inteiroSenior 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%...
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Apheresis Operations Leader
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Porto Alegre, Brasil Bebeeoperations Tempo inteiroTissue Operations Manager Job OverviewWe are seeking a seasoned professional to lead our Tissue Operations team.The ideal candidate will have extensive experience in Apheresis Operations Management, QA Operations, and GMP production.The successful candidate will be responsible for managing Apheresis and Treatment Centres used for Clinical Chimeric Antigen...
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Apheresis Operations Leader
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Porto Alegre, Brasil beBeeOperations Tempo inteiroTissue Operations Manager Job Overview We are seeking a seasoned professional to lead our Tissue Operations team. The ideal candidate will have extensive experience in Apheresis Operations Management, QA Operations, and GMP production. The successful candidate will be responsible for managing Apheresis and Treatment Centres used for Clinical Chimeric Antigen...
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