Tissue Operations Manager
Há 4 dias
The ideal candidate will oversee the management of Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies. This role serves as the technical operations single point of contact for Apheresis and Treatment Centres located within the designated region and may require management of contract employees.
">This role is remotely based to service designated regions. Regional travel up to 75% of time may be required.
">- Develop and foster relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned region.
- Work with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint to support the clinical trial 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 within the required timelines.
- Communicate collection site on-boarding status to Clinical teams and develop and execute mitigation plans for any delayed timelines.
- Perform technical site assessments and train collection center staff on 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.
Required Skills and Qualifications:
Experience in Apheresis Operations Management, QA Operations, GMP production, GTP or other relevant operational areas.
Breadth of experience in regulated (GxP) environment, understanding of HTA (either hospital or pharmaceutical/biopharmaceutical company).
Undergraduate degree in related science or nursing.
Be fluent in English and Portuguese.
Ability to rapidly solve problems and deal with organizational complexity.
Medical, scientific and clinical knowledge.
Knowledge of applicable regulations and standards.
">Benefits:
Remote work opportunity.
Opportunity to work with a dynamic team.
Professional growth and development opportunities.
">Others:
Awareness of industry trends and developments.
Excellent communication skills.
Results-oriented individual.
Strong analytical skills.
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