Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.
Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
Primary Responsibility
The Associate Director, Treatment Operations works with Process Development, Clinical Operations, Commercial Operations, Patient Supply, MS&T, and Quality to oversee and effectively manage the treatment process from leukapheresis collection through infusion.
This role is responsible for qualifying, training, and assisting Authorized Treatment Centers for commercial and clinical studies. This role ensures all patients cells are managed to the relevant standards and protocol requirements. This will include assessing/auditing site facilities suitability, process training, site assessment and qualification, ongoing site compliance, risk management, contingency planning, and ongoing performance management.
This role will work cross-functionally to assist with the development and implementation of qualification, training and monitoring programs for apheresis centers that support expansion of our cell therapy treatments in the EU and US.
This role is accountable for operational excellence improvement projects to improve Global Treatment Operations capability and ensure right first-time performance of apheresis and infusion operations.
Key Responsibilities
Lead a world class Apheresis Operations function that is focused on delivering an excellent patient and stakeholder experience as it relates to the collection and management of patient cells.
Partner with Development and Commercial Leadership to implement a sustainable apheresis and treatment center network strategy. Develop strategic plans for scaling (globally) the network of Qualified Treatment Centers to meet clinical and commercial forecasts. Manage the operational setup of new apheresis and treatment centers.
Build systems and tools that will drive data collection and analysis in support of optimizing collection procedures, efficiency, and quality.
Develop an industry leading training program for the education of internal and external stakeholders in the patient and cell journey. Train apheresis centers on the leukapheresis collection process through infusion. Ensure site training compliance versus needs / requirements. Maintain process revisions (SOPs, slide-decks, & controlled documents) and communicate timely updates to sites.
Provide Quality Systems support by participating in deviation/change management activities and impact/investigation assessments for cell collection centers. Ensure the key starting material meets the quality requirements.
Establish site qualification criteria and conduct operational certification for apheresis/treatment. Work with internal and external business partners to ensure cell collection centers successfully complete all qualification activities within the required timelines and are compliant with all necessary regulations and company policies/procedures as applicable. Track qualification activities and communicate timeline delays to team. Develop and execute mitigation plans for delayed timelines. Maintain the monitoring schedule and approved apheresis collection site list. Track and maintain site certification and recertification needs.
Identify risks and drive continuous improvement in the cell collection process through technological innovation and alignment with regulatory and commercial manufacturing requirements.
Actively seek VOC (voice of customer) and VOB (voice of business) feedback to identify, share, and implement best practices cross-functionally and between cell collection sites.
Qualifications & Experience
Required
Bachelor's degree in a relevant scientific field, and/or relevant scientific licensure (e.g. Registered Nurse, or related field) or the combination of education and direct experience in apheresis/transplant/infusion centers, or blood banks
Minimum 6 years of healthcare or related experience
Strong knowledge of clinical operations, Good Tissue Practices, and the applicable regulations and standards associated with cell therapy and/or blood products (e.g. GMP, GCP, FACT, JACIE, AABB)
Demonstrated leadership, communication, and presentation skills
Experience introducing new tools and processes within patient treatment sites
Desirable
Advanced degree in Life Sciences preferred
Management experience within Cell or Gene Therapy
Experience with process improvement strategies and change execution management
Experience developing scalable processes for an expanding business.
Experience managing external suppliers, blood banks, and plasma centres.
Medical center or pharmaceutical auditing experience preferred.
Operational Excellence / Lean Six Sigma training preferred.
other requirements
Ability to travel internationally (valid passport), initially up to 15-20% (may vary according to Government travel restrictions)
At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.
#J-18808-Ljbffr
