This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly. Job Title: Manager/Senior Manager, Apheresis and Infusion Operations Reports to: Director, Apheresis and Infusion Operations Department Product Delivery About Autolus: Autolus is a clinical-stage biopharmaceutical company developing 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 that are designed to better recognise 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 and solid tumours. Why Autolus? ur team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy 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 private medical insurance, life assurance, pension and access to an employee share scheme. Autolus promotes flexible working. Our Promise Autolus 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 Summary The Manager/Senior Manager Apheresis and 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. The Manager/Senior Manager Apheresis and Infusion Operations will not be providing patient care. The role is to provide technical support by serving as the single point of contact for Apheresis and Treatment Centres located within UK. The role may require management of contract employees. This role is field based to service the UK and potentially support designated regions of Western Europe. Regional travel up to 50% of time within UK/Europe may be required. Key Responsibilities • Develop and foster relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned region. • Perform technical site assessments and train collection centre staff on Autolus collection requirements and attend site audits as required • 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 to Autolus’ expectations 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. • Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centres. • Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch. • Foster a process improvement mindset. When required, author Standard Operating Procedures (SOPs) to ensure Autolus’ compliance with applicable regulations. • 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. Demonstrated skills and competencies E – Essential P – Preferred Experience • Experience 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 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) • Experience of navigating import/export requirements (P) Qualifications • Undergraduate degree in related science or nursing (E) • Advanced degree in related science or nursing (P) Skills/Specialist knowledge • Demonstrated agility and adaptable to dynamic and unfamiliar situations, a creative thinker. • 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 (e.g. 21 CFR 1271, HTA regulations and EU Tissue and Cells directives, EU ATMP GMP regulations, FACT / JACIE, import/export, and local regulations). • Excellent attention to detail and a desire to follow work through to completion • Excellent organization skills with ability to multi-task several tasks in parallel • Customer-centricity — Consider the impacts of decisions on the customer (treatment centre), striving to ensure that Autolus process changes improve and do not impede customer service when possible, while ensuring compliance with regulations • Excellent interpersonal and presentation skills to advocate for and represent Autolus, communicate effectively across all levels within the organization and multiple cultures • Fluent spoken English (E). Other European languages, including German, French and Spanish would be an advantage. Autolus Leadership Behaviours (incorporating Core Competencies) Clarify direction and inspire; Using good judgement to set clear and compelling goals that show your team how their work contributes to our purpose and strategy Deliver goals and plans; Creating joint plans with your team to deliver your goals, holding yourself and others accountable for delivering quality results Work collaboratively; Cultivating a network of relationships across the organisation and building high performing teams based on mutual trust and respect Optimise potential; Creating a healthy, engaged and empowered working environment that invests in people and their development Role Model our values; Acting as a role model ensuring everything you do is in line with our values of respect, integrity, focus and breakthrough LI-DNI