|部署・役職名||Manager, Patient Operations – Apheresis|
Manager, Patient Operations – Apheresis is accountable to manage onboarding and on－going performance of Apheresis Centers used for Clinical and Commercial Chimeric Antigen Receptor （CAR） T－cell Therapies. This role will serve as the technical operations single point of contact for Apheresis Centers located within the designated region of Japan.
This role will be based out of the corporate offices in Tokyo, Japan. Travel up to 60％ of time within Japan may be required.
Develop and foster relationships with Apheresis Center Staff for assigned region.
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/country.
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 the company 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 the company 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.
【必須（MUST）】Qualifications ＆ Experience
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
High attention to detail skills
High organization skills with ability to multi－task several tasks in parallel
Required Undergraduate Degree in Life Sciences or Engineering （Registered Nurse, Biomedical Engineer）
Required minimum 5 years of experience in a regulated environment either hospital or pharmaceutical/biotech
Required written and verbal fluency in Japanese and English