Manager, Tissue Operations

Using a broad suite of proprietary and modular T cell programming technologies.Role SummaryThe Manager, Tissue Operations is accountable for managing onboarding and on-going 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 and may require management of contract employees.This role is remotely based to service designated regions.

Regional travel up to 75% of time may be required.Key ResponsibilitiesDevelop 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 requiredProvide 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 improvementCollect and enter data into electronic data management systemsRepresent the department on cross-functional project teams, as requested.Comply with applicable SOP's and regulations.Demonstrated skills and competenciesExperience Required : Experience in Apheresis Operations Management, QA Operations, GMP production, GTP or other relevant operational areasBreadth of experience in regulated (GxP) environment, understanding of HTA (either hospital or pharmaceutical / biopharmaceutical company)Experience working with critical raw material suppliers or contract manufacturing organizationsHas successfully worked in a team-based environment.Experience in delivering process improvements, ideally in processes for qualification, training, and management of external cell procurement (Apheresis) suppliers.Undergraduate degree in related science or nursingBe fluent in English and PortugueseExperience Preferred : Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programsExperience in an operational role for supplier qualification and management of external Apheresis, Cellular Therapy or Stem Cell Transplant programs.Experience managing contracts with external apheresis providers.Prior customer facing role in pharmaceutical / biotech industryAdvanced degree in related science or nursing (P)Skills / Specialist knowledgeAbility to rapidly solve problems and deal with organizational complexityAbility to prioritize and complete work with sense of urgency based on criticalityMedical, scientific and clinical knowledgeKnowledge of applicable regulations and standardsHigh attention to detail skillsHigh organization skills with ability to multi-task several tasks in parallelCustomer-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 regulationsExcellent interpersonal and presentation skills to communicate effectively across all levels within the organization and multiple cultures