Associate Director, Apheresis Patient Operations

Introduction to role

The Associate Director, Apheresis Patient Operations, will lead all aspects of the onboarding and ongoing management of the apheresis center network and cell therapy labs (CTL) supporting AstraZeneca’s portfolio of clinical cell therapies. This role ensures adherence to AstraZeneca standards and requirements, maintaining consistency throughout the cell journey and ensuring compliance with Chain of Identity and Chain of Custody protocols. You will lead a team of technical operations experts, serving as a point of contact for internal and external customers, managing apheresis collection, packaging, shipping, and providing day-of and in-person support as needed.

Accountabilities

• Manage feasibility assessments to determine site capabilities to support AZ cell therapies.

• Coordinate apheresis and CTL network performance, including third-party organizations.

• Support sites in an on-call status for apheresis virtually and in-person when required.

• Travel to sites to implement mock runs for training and refresher purposes when required.

• Coordinate apheresis logistics between 3rd party vendors and Centers of Excellence.

• Develop, lead, and implement seamless communication at sites new to cell therapy and apheresis procedures.

• Support a risk-based apheresis onboarding plan across all products within the AstraZeneca Cell Therapy Program.

• Manage onboarding activities and ongoing performance of the apheresis collection centers and CTL according to AZ requirements.

• Review, approve, and act as point of contact for Apheresis Agreements for internal and external customers.

• Collaborate with Clinical Operation, Quality Assurance, and Technical Operations to define the requirements for cells as starting materials.

• Report apheresis collection centers onboarding status to internal teams and develop mitigation plans for delayed timelines.

• In collaboration with the Quality team, qualify the collection centers and monitor ongoing performance.

• Maintain and report apheresis collection data metrics as required.

• Create and update AZ Apheresis manual, forms, and procedures associated with apheresis collection.

• Ensure all applicable documents associated with the Apheresis collection, packaging, and shipping are stored and maintained per applicable local and national regulatory requirements.

• Ensure apheresis collection centers hold applicable accreditations (e.g., FACT, if required).

• Create and maintain COI/COC process.

• Lead all aspects of the training of collection center staff on AZ collection, packing, and shipping requirements as needed.

• Provide support through management of investigations and impact assessments for any deviations associated with apheresis collection centers and CTL.

• Ensure timely notification to Apheresis collection sites and CTL when issues are discovered.

• Represent the department on cross-functional project teams (Site Engagement, Logistics, Quality, Clinical, Commercial, and global) as requested.

• Ensure compliance with all applicable regulations and standards related to the use of Human Blood and Tissue Products for use in Pharmaceutical Products.

• Lead/Contribute Change Control assessments as applicable.

• Contribute to oversight of Cell Orchestration platform.

• Source and procure allogeneic cells if needed.

• Monitor and evaluate the quality metrics of Apheresis Collection sites.

• Work with logistics to ensure the secure storage and transportation of cells.

• Manage cell source documentation, including quality control records, shipment records, and batch records.

• Lead/contribute to identify and initiate process improvement measures.

• Collect VOC (voice-of-customer) and VOB (voice-of-business) feedback used for continuous operations improvement.

• Support coordinate vein-to-vein supply chain within the US and ex-US.

• Hire and train Apheresis Patient Operations team.

• Mentor, coach, and develop direct reports.

• Support global studies and teams as needed.

Essential Skills/Experience

• Bachelor’s Degree in life sciences field (or nursing certificate/diploma) with 10 years of experience in a hospital or pharmaceutical/biotech, apheresis or cell therapy operations management.

• Experience working in Apheresis or Cell Therapy.

• Knowledge of applicable regulations and standards related to Apheresis collections and labelling (21 CFR Part 1271, FACT/JACIE, ISBT 128/ICCBAA).

• Fosters an environment of open communication and respect.

• Experience working with vendor or contract manufacturing organizations (CMO).

• Good knowledge of international standards for cell collection and donor requirements.

• Excellent verbal, written, and presentation skills; able to communicate effectively with all levels of management.

• Expertise/knowledge in critical thinking, influence, negotiation, problem-solving, critical thinking, and leadership in a matrix environment.

• Demonstrated strong leadership skill; able to make timely decisions accounting for quality and risk.

• Team player with the ability to influence other areas not under direct control to achieve objectives; effectively communicate ambitious goals and objectives.

• Ability to work in a virtual environment; able to build strong relationships in virtual settings.

• Experienced people manager.

• Self-starter.

• Travel requirement approximately 25% (including travel to apheresis centers and internal business meetings as needed).

Desirable Skills/Experience

• Experience working in a regulated environment (cGMP/GCP/GTP) preferred. To include international standards for Apheresis collections.

• Experience working in Cell Therapy, Apheresis or Stem Cell Transplant programs preferred.

• Advanced degree or equivalent experience in the Life Sciences or Nursing is a plus.

• Prior customer-facing role in pharmaceutical/biotech industry.

• Experience working with critical raw material suppliers.

• Proficient in other languages is a plus.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are driven by our bold ambition to eliminate cancer as a cause of death. Our Oncology Business Unit relentlessly follows the science to deliver more effective treatments to patients in need. We push back the limits of knowledge to change the practice of medicine. Our commitment ensures no patient is left behind. We are entrepreneurial pioneers who step up to take personal accountability in our ever-evolving environment. With access to industry-leading research, technology, and product launches from our game-changing pipeline, you will find varied opportunities to accelerate your career.

Join us on this exciting journey. Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.