Associate Director, Apheresis & Infusion Operations

Autolus-Ltd-; Stevenage; Hybrid; GBP 90,000 - 130,000; Full time

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.

Skills

Apheresis Operations

GxP/Regulatory

QA/Deviations

Cell Therapy/Stem Cell Programs

Contract Management

Customer Facing/Stakeholder Management

Process Improvements

Education

Undergraduate degree in related science or nursing

Advanced degree in related science or nursing

Job description

Work with usOur team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and Autoimmune disease to deliver life-changing treatments to patients.Whilst working at Autolus you will enjoy a flexible, diverse and dynamic working environment which actively promotes creativity, leadership and teamwork – together we are ONE Autolus.Job Description:Job Title: Associate Director, Apheresis & Infusion OperationsReports to Director, Apheresis & Infusion OperationsDepartment: Patient Cell & ManagementHours: Monday – Friday (core office hours)Location: Stevenage (hybrid working)About AutolusAutolus is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defence mechanisms, and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies, solid tumours, and autoimmune diseases.Why AutolusOur team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and autoimmune diseases to deliver life-changing treatments to patients. Whilst working at Autolus you will enjoy a flexible, diverse, and dynamic working environment which actively promotes creativity, leadership and teamwork. In addition to this Autolus is proud to offer a competitive salary, performance related bonus as well as a comprehensive benefits package.Our PromiseAutolus is developing complex, breakthrough therapies for a globally diverse market and equally recognises that diversity amongst our people is critical to our mission. As we draw on our differences, what we’ve experienced, and how we work, we celebrate diversity and are committed to creating an inclusive environment for all employees.Role SummaryThe Associate Director, Apheresis & Infusion Operations is accountable for managing onboarding and on-going performance of Apheresis and Treatment Centres used for Autolus Clinical and Commercial Chimeric Antigen Receptor (CAR) T-cell Therapies. This role will serve as the technical operations single point of contact for Apheresis and Infusion at Treatment Centres located in the United Kingdom and Rest of World (all countries outside of America). and may require management of contract employees. Up to 50% travel maybe required within the U.K. but occasionally to other regions mainly within the European Union.Key ResponsibilitiesssDevelop and foster relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned region.Act as the single point of technical expertise for Apheresis and Infusion requirements relating to Autolus activities.Work with Apheresis and Treatment Centres to resolve technical issues relating to Autolus activities.Work with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint to support the clinical trial and commercial 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 for Autolus within the required timelines.Communicate collection site on-boarding status to Clinical and Commercial teams and develop and execute mitigation plans for any delayed timelines.Perform technical site assessments and train collection center staff on Autolus collection requirements and attend site audits as requiredProvide 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 improvementCollect and enter data into electronic data management systemsRepresent the department on cross-functional project teams, as requested.Comply with applicable SOP’s and regulations.Demonstrated skills and competenciesE – EssentialP – PreferredExperienceExperience in Apheresis Operations Management, QA Operations, GMP production or other relevant operational areas (E)Breadth of experience in regulated (GxP) environment (either hospital or pharmaceutical/biopharmaceutical company) (E)Experience with quality systems and processes, document control, deviations and change controls (E)Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs (P)Experience working with critical raw material suppliers or contract manufacturing organizations (E)Experience in an operational role for supplier qualification and management of external Apheresis, Cellular Therapy or Stem Cell Transplant programs. (P)Has successfully worked in a team-based environment. (E)Experience in delivering process improvements, ideally in processes for qualification, training, and management of external cell procurement (Apheresis) suppliers. (E)Experience managing contracts with external apheresis providers. (P)Prior customer facing role in pharmaceutical/biotech industry (P)Qualifications Undergraduate degree in related science or nursing (E) Advanced degree in related science or nursing (P)Skills/Specialist knowledgeAbility to rapidly solve problems and deal with organizational complexityAbility to adapt to change and working in uncertain environmentsKnowledge of International society for blood transfusion (ISBT) and JACIE standardsExcellent understanding of the Human Tissue Authority regulationsAbility to prioritize and complete work with sense of urgency based on criticalityMedical, scientific and clinical knowledgeKnowledge of applicable regulations and standardsHigh attention to detail skillsHigh organization skills with ability to multi-task several tasks in parallelCustomer-centricity — Consider the impacts of decisions on the customer (treatment center), striving to ensure that Autolus process changes improve and do not impede customer service when possible, while ensuring compliance with regulationsExcellent interpersonal and presentation skills to communicate effectively across all levels within the organization and multiple culturesAutolus Core CompetenciesFocus on Results: Works to meet business goals set by management and leadersBuilds Trust and Relationships: Ensures trust with internal and external partners by delivering on commitmentsResilience: Has the capacity to recover quickly from difficulties; toughnessCommunicates and Collaborates: Builds partnerships and works collaboratively with others to meet objectivesAutolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR)Autolus is committed to providing an inclusive and fair workplace for all. We are an equal opportunity employer and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. We also provide reasonable accommodations where appropriate.Autolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR).Autolus is committed to providing an inclusive and fair workplace for all. We are an equal opportunity employer and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. We also provide reasonable accommodations throughout the recruitment process.Autolus’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard. Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry.