Cell Therapy Operations Specialist
Há 21 horas
Job Description:We are seeking a highly skilled and experienced Cell Therapy Operations Specialist to join our team.
In this role, you will be responsible for managing the onboarding and ongoing performance of Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies.The successful candidate will serve as the technical operations single point of contact for Apheresis and Treatment Centres located within a designated region and may require management of contract employees.
This role is remotely based and requires regional travel up to 75% of the time.Key Responsibilities: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 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 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.Required Skills and Qualifications: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.Proven 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.Benefits:This role offers a challenging and rewarding opportunity to work in a dynamic and growing industry.
The successful candidate will have the opportunity to make a significant impact on the success of our organization.
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