Associate Director, Apheresis & Infusion Operations

Autolus Therapeutics plc; Stevenage; Híbrido; GBP 100.000 - 150.000; Jornada completa

Descripción de la vacante

Autolus Therapeutics plc in Stevenage is seeking an Associate Director, Apheresis & Infusion Operations to lead onboarding and ongoing performance of Apheresis and Treatment Centres supporting Autolus CAR-T therapies. The role covers UK and Rest of World with travel up to 50% and may involve management of contract staff.

You will partner with QA, Clinical and Commercial teams to establish site readiness, ensure compliant operations and deliver on timelines while maintaining ISBT/JACIE standards.

Formación

• Experience in Apheresis Operations Management in regulated environments.
• GxP experience in hospital or pharma/biotech settings.
• Experience with quality systems, deviations, change controls and document control.

Responsabilidades

• Develop and manage onboarding and performance of Apheresis and Treatment Centre sites.
• Serve as technical operations single point of contact for Apheresis and Infusion.
• Collaborate with QA, Clinical and Commercial teams to ensure site readiness and timelines.
• Coordinate vendor performance and capacity after site launch and manage external providers.
• Lead process changes rollout and capture voice of customer/business for improvements.

Conocimientos

Apheresis Ops

GxP Compliance

Vendor Management

Quality Systems

Operational Leadership

Cell Therapy

ISBT/JACIE knowledge

Project Collaboration

Educación

Undergraduate degree in related science or nursing

Advanced degree in related science or nursing

Descripción del empleo

Work with us

Our 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 Operations

Reports to Director, Apheresis & Infusion Operations

Department: Patient Cell & Management

Hours: Monday – Friday (core office hours)

Location: Stevenage (hybrid working)

About Autolus

Autolus 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 Autolus

Our 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.

Autolus is proud to offer a competitive salary, performance related bonus as well as a comprehensive benefits package .

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 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 Responsibilitiesss

• Develop 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 required
• Provide 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 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 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 knowledge

• Ability to rapidly solve problems and deal with organizational complexity
• Ability to adapt to change and working in uncertain environments
• Knowledge of International society for blood transfusion (ISBT) and JACIE standards
• Excellent understanding of the Human Tissue Authority regulations
• Ability to prioritize and complete work with sense of urgency based on criticality
• Medical, scientific and clinical knowledge
• Knowledge of applicable regulations and standards
• High attention to detail skills
• High organization skills with ability to multi-task several tasks in parallel
• Customer-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 regulations
• Excellent interpersonal and presentation skills to communicate effectively across all levels within the organization and multiple cultures

Autolus Core Competencies

• Focus on Results: Works to meet business goals set by management and leaders
• Builds Trust and Relationships: Ensures trust with internal and external partners by delivering on commitments
• Resilience: Has the capacity to recover quickly from difficulties; toughness
• Communicates and Collaborates: Builds partnerships and works collaboratively with others to meet objectives

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 accommodationswhereappropriate.

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.