Apheresis & Infusion Principal

Description:

• Bachelor's degree
• Strong apheresis and/or cellular therapeutics operations background/knowledge; Recent blood and marrow transplant experience
• Infusion therapy understanding, involving complex therapies
• Effective training and sound presentation skills
• Working knowledge or exposure to GCP and GMP
• Must be willing to travel up to 80%; may include weekend travel
• Ability to be succeed in a fast-paced environment
• Ability to work independently with limited supervision
• Effective decision making, priority setting and delegation skills
• Effective training, planning and problem-solving ability
• Detail-oriented and able to assess and assimilate data and communicate objectively
• Excellent collaboration skills; establish good relationships with ATC staff and internal teams
• Competent computer skills (MS office, Cloud-based programs, Quality Management Systems)
• Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately
• Strong command of both English and Arabic.
   

Key Responsibilities
 

• Work with the Director of AIS, to lead/co-lead ATC activities linked to Apheresis & Infusion and drug product handling activities within given territory
• Evaluates treatment centers as part of ATC activation and confirms to Vertex whether the ATC has the capability to: A - adhere to technical requirements for drug product therapy; B- comply with standards established by the ATCs and all applicable regulatory and licensing bodies
• Provides on-site and/or remote training, oversight, and direction to facilitate the ATC in complying with technical requirements for drug product therapy
• During coverage of collection and infusion procedures, serve as liaison between the ATC staff and Vertex commercial manufacturing and supply chain operations
• Provides on-site / remote (off-site) support to ATC staff as needed to optimize collection and infusion activities. Note: this activity could require being in the same room as the patient but there must not and will not be any interactions with the patient. This may require coordinating travel to coincide with the patient visits.
• Adhere with all applicable policies of the ATC (as informed and required by the ATC) as necessary for the AIS to carry out the AIS role
• Assist with response, mitigation, and escalation of identified or potential issues at or related to ATCs, with robust follow-up of issues and support for ATC improvement efforts
• Serves as a key member of the Vertex cross functional team in the country to provide continuous feedback on ATC performance regarding the apheresis and infusion process required for the Vertex gene editing therapy
• Provides feedback and recommendations to the ATC for apheresis & infusion process improvements and documents, manuals, guides, and work instructions to optimize compliance with the Apheresis & Infusion manuals and the drug product handling guidelines
• Fosters positive collaborative relationships with assigned ATCs
• Is responsible for ensuring all AIS on-site visits and communications are conducted and documented in accordance with (i) Vertex policy; (ii) any agreed requirements of the relevant ATC; and (iii) all applicable laws, regulations and industry codes, and requirements of licensing and regulatory bodies (including local regulations and codes of the country within which the ATC is located).
• Support systems and teams at the ATC in the optimization of collection procedures, efficiency, and quality
• Actively engages in the identification, sharing, and adaptation of best practices with ATCs
• Work closely with the Vertex Commercial Manufacturing and Supply Chain function to ensure the traceability of patient cell collection and drug production infusion through the patient treatment pathway
• Note: AIS is not responsible for providing the following: practice of medicine, provision of patient care, patient interactions, making determinations regarding patient’s eligibility for any treatment, discussing patient condition or treatment, independently collecting data, collecting, or retaining patient personal identifiable information (including health information), or interpreting or advising on the marketing authorization / product license of the Vertex gene editing therapy or any other medicinal product or treatment (outside of the requirements of Apheresis & Infusion manuals and drug product handling guidelines).