Manager/ Senior Manager Apheresis & Infusion Operations - Germany

at  Autolus Ltd

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 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 advocate for and represent Autolus, communicate effectively across all levels within the organization and multiple cultures
• Fluent spoken German (E) and English (E). Other European languages, particularly Spanish would be an advantage.

ROLE SUMMARY

The Manager/Senior Manager Apheresis and Infusion Operations is accountable for managing onboarding and on-going performance of Apheresis and Treatment Centers 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 Centers located within Germany. The role may require management of contract employees.
This role is remotely based to service designated regions of Western Europe. Regional travel up to 75% of time within Europe may be required.

KEY RESPONSIBILITIES

• Develop and foster relationships with Apheresis, Cell Lab and Treatment Center Staff for assigned region.
• Perform technical site assessments and train collection center 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 centers.
• 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.