Dept: Distribution, Logistics & Site Qualification
Location: London, UK
Reporting to: Director Global Supply Chain
Job Summary
The Specialist, Global Supply Chain will be responsible for the coordination of the logistics and distribution of Gene Therapy products for commercial, clinical and compassionate use patients between the Qualified Treatments Centres (QTC) worldwide and the Contract Development and Manufacturing Organization (CDMO), as well as shipment of other GMP material among CDMOs. In addition, the post holder will also co-ordinate operational labelling activities for both clinical and commercial products.
In addition to the above, the Specialist, Global Supply Chain will support the cross functional SQWT (Site Qualification Working Team) making sure hospitals around the globe are familiar with and trained to the Orchard processes to treat patients.
Key Elements and Responsibilities
Global Patient Supply
· Coordinate clinical and commercial patient treatment logistics with QTC, Logistics provider, broker, distributors and CDMO.
· Ensure seamless and compliant drug product supply from enrolment and cellular source collection to drug product delivery.
· Keep Patient Scheduling up to date together with the manufacturing & scheduling team.
· Manage printing patient specific labels required for commercial and clinical patient treatment. Work with QTC, CDMO label providers and Quality Assurance (QA) for labels approval, delivering labels and meeting deadlines.
· Initiate and maintain Chain of Identity Identifier (COI ID) for each patient treatment and manage COI traceability and Chain of Custody (COC) processes throughout the entire patient and product journey to ensure safe and compliant patient treatment.
· Participate in country-level update meetings as the patient supply logistics subject matter expert, partnering with commercial, medical affairs, regulatory and market access.
GMP Logistics
· Organise shipments between multiple contract manufacturing sites.
· Build effective operational relationships with logistic providers including leading regular meetings with them
· Schedule and arrange collections of materials with couriers, supporting CMC teams when required.
· Ensure import and export permits are in place as required. Partner with legal, tax and finance to complete necessary shipping and customs documentation.
· Maintain shipment log and documentation records.
Site Qualification Support
· Organise or support the Site Qualification Kick Off meeting
· Lead or support the the Site Assessment process
· Lead or support the Mock Shipment process
Business Process
· Work to GMP, GCP, GDP standards required and complete documentation to GMP standard.
· Write and review Standard Operating Procedures and other GMP and non-GMP documentation as requested, including Veeva documentation updates.
· Raise purchase orders for assigned vendors through NetSuite.
· Contribute to process improvement and standardization of logistics processes.
· Perform other tasks and assignments as needed and specified by management.
Requirements
Required Knowledge & Skills
· Customer service mindset and patient oriented
· 3+ years of Logistics and Distribution experience in pharmaceutical/biotech industry
· Skilled in writing and reviewing SOPs and work instructions
· Ability to operate in a fast-paced, multi-disciplinary environment
· Strong commitment to accuracy and attention to detail
· Good understanding of Good Manufacturing Practices (GMP) and regulatory requirements
· Ability to work independently and with good verbal and written communication skills
· Must be able to: multi-task, be flexible, work in a close-knit team-oriented atmosphere
· Language: Fluency in English is essential, any other language is an asset
Education
· Bachelor’s degree or equivalent pharmaceutical experience
