Clinical Supply Chain Manager
|Area||M4 Corridor, UK|
|Sector||Pharma / Biotech|
|Salary||£ 50,000 ~ 60,000 Competitive|
We are currently partnering with a clinical-stage Biotech company based in Oxford who are looking for a Clinical Supply Chain Manager. This role is responsible for the management of the manufacture, logistics and supply chain of drug material to clinical trial centres and patients. Working in collaboration with external vendors and internal Clinical Operations, Regulatory, CMC and Quality teams, this role will ensure the strategic planning, management and co-ordination of external warehousing, inventory, packaging, labeling, shelf-life, distribution and customs processes for our drug supply.
LOCATION: South Oxford
- Develop manufacturing and supply options, facilitate decision-making, and communicate updated plans to all impacted stakeholders.
- Effective management and control of annual supply chain budgets and meet agreed spending targets.
- Develop and update Key Performance Indicators for the execution and tracking of supply chain activities.
- Proactively identify, lead and resolve manufacturing and supply chain problems/barriers
- Support / lead the selection, negotiation and set up process for supply chain vendors.
Manufacture & Distribution
- Work proactively with Clinical Operation/Study team to help create forecast for ongoing studies to ensure inventory re-supply for assigned clinical programmes are managed effectively.
- Monitor enrollment, drop-out rates and actual supply needs on assigned protocols and/or programmes. Ensure continuous re-assessment of project needs, on assigned programmes and/or protocols.
- Plan and initiate clinical trial material manufacturing at contract manufacturing organisations
- Co-ordinate the initiation and internal approval of Purchase Orders for supply chain related activities
- Drive label and artwork creation and approvals, including translations for all countries, on assigned study and/or program responsible for.
- Communicate updates to internal stakeholders on progression of clinical trial material through the supply chain
- Oversee courier & country logistics for shipping and importation as well as maintain shipment logs and documentation records and follow up on shipments and receipt of materials.
- Monitor regularly drug expiry, and the appropriate inventory re-supply for assigned clinical programs
- Support return and destruction of clinical drug material from sites to depots for assigned study
- Work to GMP and complete docs to GMP standard
- Attend vendor meetings such as project kick-off, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals.
- B.Sc. in a biological or scientific field
- Experience in clinical supply and pharmaceutical development in relevant capacity required, including supply chain planning, operations, or scheduling including experience in cell or gene therapy.
- Experienced in working with third-party contract manufacturing sites and clinical supply operations.
- Demonstrable and strong understanding and experience of GMP and GCP
For further information please get in touch with Natalie Jones via firstname.lastname@example.org or call 02071835059