Associate Director Product Development and Supply

We are currently partnering with a clinical-stage Biotech company based in Oxford who are looking for an Associate Director of Product Development and Supply.

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, labelling, shelf-life, distribution and customs processes for our drug supply. 

LOCATION: Oxford

Responsibilities

Strategic Planning

• Develop manufacturing and supply strategies and initiatives to include multiple 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 evaluate Key Performance Indicators for the execution and tracking of 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.
• Select contractors in accordance with policies for contracting out GMP, GLP and GCP work
• Ensure that work outsourced to contractors is delivered on budget, on time and to the appropriate technical and quality standards.

Product Development

• Provide strategic and technical input to CMC activities including characterisation, analysis and specifications
• Provide strategic formulation development input
• Be responsible for the product life-cycle management
• Responsible for the technical content of all product development activities including product development, process development, validation and scale-up

Regulatory / Compliance

• Ensure business compliance with cGMP/GDP as well as internal SOPs/ICH and appropriate quality agreements
• Write/review SOP’s to support QMS in collaboration with the QA team
• Write, review and approve technical documentation required for regulatory submission of IND’s, IMPDs, BLA and MAA
• Responsible for the technical content of CMC documents supporting regulatory filings.

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

Qualifications

• 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 and negotiating with third-party contract manufacturing sites and clinical supply operations, including in delivering technical agreements and product specifications
• Experience in commercialising IMPs to marketed products, including formulation, stability and up scaling the manufacturing process

For further information please get in touch with Natalie Jones via natalie@linkfieldgroup.com or call 02071835059