Senior Operations Manager for Tissue and Cell Therapy

1 dia atrás

São Paulo, São Paulo, Brasil beBeeOperations Tempo inteiro R$120.000 - R$150.000
Job Title: Senior Operations Manager for Tissue and Cell Therapy

As a seasoned professional in the field of tissue and cell therapy, we are seeking a highly skilled Senior Operations Manager to oversee the onboarding and ongoing performance of Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies. This role will serve as the technical operations single point of contact for Apheresis and Treatment Centres located within designated regions and may require management of contract employees.

This is a remotely based position that requires regional travel up to 75% of the time. The ideal candidate will possess excellent communication skills, be fluent in English and Portuguese, and have a strong background in operations management, QA, and GMP production.

Key Responsibilities:
  • Develop and foster relationships with Apheresis, Cell Lab, and Treatment Centre Staff for assigned regions.
  • Work with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint to support clinical trial site plans for assigned regions.
  • 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 required timelines.
  • Communicate collection site onboarding 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.
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).
  • Experience working with critical raw material suppliers or contract manufacturing organizations.
  • Has successfully worked in a team-based environment.
  • Experience in delivering process improvements, ideally in processes for qualification, training, and management of external cell procurement (Apheresis) suppliers.
  • Undergraduate degree in related science or nursing.
Benefits:
  • Fluency in English and Portuguese.
  • 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.
  • Customer-centricity — Consider the impacts of decisions on the customer (treatment centre), striving to ensure that 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.
Seniority Level:
  • Mid-Senior level.
Employment Type:
  • Contract.
Job Function:
  • Other.
Industries:
  • Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care.

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