Senior Apheresis & Infusion Operations Lead

Autolus-Ltd-

Stevenage

Hybrid

GBP 90,000 - 130,000

Full time

10 days ago

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Job summary

Autolus is seeking an Associate Director for Apheresis & Infusion Operations in Stevenage with hybrid working. You will manage onboarding and performance of Apheresis and Treatment Centres for CAR-T therapies, acting as the technical expert and coordinating with Clinical and Commercial teams.

You will build relationships with centre staff, train on Autolus collection requirements, support QA activities, and drive continuous improvement across vendor performance and site readiness in the UK and

Qualifications

Undergraduate degree in related science or nursing.
Advanced degree in related science or nursing.
Experience in Apheresis Operations Management or GMP-related roles.
Experience in regulated (GxP) environments (hospital or biopharma).
Experience with Apheresis, Cellular Therapy or Stem Cell Transplant programs.
Experience managing external Apheresis providers and supplier qualification.
Prior customer-facing role in pharma/biotech industry.
Knowledge of ISBT/JACIE standards beneficial.

Responsibilities

Develop and foster relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned region.
Serve as the single point of technical expertise for Apheresis and Infusion requirements in Autolus activities.
Coordinate onboarding activities and ensure sites are prepared for collections.
Communicate onboarding status to Clinical and Commercial teams and mitigate delays.
Train collection center staff on Autolus collection requirements and participate in audits.
Provide Quality Systems support by participating in deviations and investigations.
Monitor vendor performance and capacity after site launch.
Roll out process changes to assigned sites.
Collect VOC and VOB feedback for continuous improvement.
Represent the department on cross-functional project teams.
Ensure SOP and regulatory compliance throughout operations.