Senior Cellular Therapy Operations Specialist
Há 3 dias
Our company is partnering with a clinical-stage biopharmaceutical organisation that develops next-generation programmed T cell therapies for cancer treatment.
Key Responsibilities- Develop and foster relationships with medical professionals to support assigned region.
- Work with clinical and commercial teams to establish a collection footprint to support site plans for assigned region.
- Coordinate with internal teams and staff to ensure all onboarding activities are successfully completed and sites are prepared to perform collections within required timelines.
- Communicate site on-boarding status to clinical teams and develop mitigation plans for any delayed timelines.
- Perform technical site assessments and train staff on collection requirements and attend site audits as required.
- Provide Quality Systems support by participating in deviation activities and impact/investigation assessments.
- Work with 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.
The ideal candidate will possess demonstrated skills and competencies:
Essential skills include breadth of experience in regulated GxP environments, understanding of HTA, and experience working in cellular therapy or stem cell transplant programs. Preferred skills include experience managing contracts with external providers and prior customer-facing roles in pharmaceutical/biotech industries. Qualifications include an undergraduate degree in a related science or nursing field, with advanced degrees preferred. Fluency in English is essential, while proficiency in Portuguese is also beneficial.
Required skills and qualifications include ability to rapidly solve problems and deal with organisational complexity, prioritise 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 organisation skills with ability to multi-task several tasks in parallel, customer-centricity, excellent interpersonal and presentation skills.
This role offers the opportunity to work in a dynamic and collaborative environment, supporting the development of innovative treatments for cancer patients. The successful candidate will be able to make a meaningful contribution to the success of our team and drive forward-thinking solutions.
Responsibilities and Skills
• Develop and maintain relationships with healthcare professionals and stakeholders
• Coordinate and execute operational processes across multiple locations
• Ensure compliance with regulatory requirements and industry standards
• Collaborate with cross-functional teams to achieve strategic objectives
• Foster a culture of innovation and continuous improvement
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