The Sr Manager Apheresis and Cell Therapy Operations is responsible for developing the processes and procedures to onboard and then management of the Apheresis Centers and Cell Therapy Centers used for AstraZeneca Clinical CAR T-cell Therapies. This role will serve as the technical operations single point of contact for Apheresis and Cell Therapy Centers.
- Establish apheresis/cell therapy site qualification criteria, documents/process and then conduct technical site assessments and training for AstraZeneca clinical trials.
- Create Apheresis and Product Administration manuals and forms that are product specific and consistent across all active trials
- Develop and foster relationships with apheresis/cell therapy site managers/staff for assigned region.
- Work with Clinical teams to establish the apheresis/cell therapy footprint to support the AstraZeneca clinical trials.
- Contribute to the development of the Cell Orchestration Platform with regards to the apheresis and cell therapy specific interfaces.
- Coordinate with internal teams and apheresis/cell therapy site staff to ensure all collection site onboarding activities are successfully completed and sites are prepared to support within the required timelines.
- Communicate apheresis/cell therapy site on-boarding status to Clinical teams and develop and execute mitigation plans for any delayed timelines.
- Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for apheresis/cell therapy centers.
- Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch.
- Develop, maintain, and evaluate key performance indicators for patient treatment execution
- 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.
- The exact accountabilities will differ depending on the stage of the clinical program, so a high degree of flexibility and autonomy is required.
Skill and Knowledge Requirements:
- 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 (US and UK/EU)
- High attention to detail skills
- High organization skills with ability to multi-task several tasks in parallel
- Required Undergraduate Degree in Life Sciences or Engineering (Registered Nurse, Biomedical Engineer)
- Experience in a regulated environment either hospital or pharmaceutical/biotech
Preferred but not required:
Working at AstraZeneca
- Advanced degree in the Life Sciences or Engineering (e.g. Pharm D, NP, PA, Biomedical Engineer)
- Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs
- Prior customer facing role in pharmaceutical/biotech industry
- Experience working with critical raw material suppliers or contract manufacturing organizations
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