Senior Risk Manager

RBW Consulting are partnered with a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognise cancer cells, break down their defence mechanisms and eliminate these cells. They have a pipeline of product candidates in development for the treatment of haematological malignancies and solid tumours.

The Senior Manager - Tissue Operations is accountable for managing onboarding and on-going 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 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.

Key Responsibilities

• 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 SOPs and regulations.

Demonstrated skills and competencies:

P – Preferred

Experience

• Experience in Apheresis Operations Management, QA Operations, GMP production, GTP or other relevant operational areas (E). Breadth of experience in regulated (GxP) environment, understanding of HTA (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).

Qualifications

• Undergraduate degree in related science or nursing (E).
• Advanced degree in related science or nursing (P).
• Be fluent in English and Portuguese (E).

Skills/Specialist knowledge

• 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

Application note

Please apply here and Harry Henson will be in touch to discuss your application further.