Supply Planner & External Manufacturing Specialist

At mAbxience, a company specialized in the development and manufacturing of biosimilar medicines, we are hiring a Supply Planner & External Manufacturing Specialist for our Manufacturing Site in León (Spain).

GLOBAL RESPONSIBILITY

The Supply Planner & External Manufacturing Specialist is responsible for managing production of pharmaceutical products performed in external vendors (CMOs). Its main responsibility is secure a smooth and efficient production as per Supply chain demand. The Drug Product collaborates with cross-functional departments to plan, manage and drive Fill & Finish activities within agreed quality, scope, budget and time. Builds and maintains productive relationships with a wide variety of internal and external stakeholders. Ensures fluent communication between API and CMO sites, building and managing a solid process flow.

SPECIFIC RESPONSIBILITIES

Drug Product Supply responsibilities :

• Ensure that Finish Products planning, manufacturing and supply in external vendors (CMO) meets commercial and non-commercial demand (clinical, developments).
• Working closely with Launch department, technical MSAT teams and CMO Supply teams to support Implementation of new drug product (DP) and new launches / NPI.
• Oversite and optimization of aseptic fill / finish processes and plans for mAbxience products.
• Deploy and align with CMO a robust manufacturing plan with 12-18 months horizon that is align with customer demand, critical resource capacity and business plan.
• Track evolution of manufacturing performance. Establish and report KPI to support Supply Chain and business targets.
• Prepare and communicate timelines associated to pre commercialization DP manufacturing.
• Generate and communicate data and information with necessary departments like regulatory, Quality or Supply Chain. Support during evaluation of quality deviations and corrective actions.
• Support the pre commercial manufacturing activities (demo runs, engineering runs, PPQs, etc)
• Develop effective forecasts based on customer demand and support the commercial team. Conduct monthly forecast maintenance. Track Demand vs Forecasts.
• Coordination of new launches and ongoing production together with third parties and internal stakeholders.

Governance and oversight :

Continuous Improvement & Innovation :

REQUIREMENTS AND PERSONAL SKILLS

Mabxience is a company committed to equal opportunities, and therefore, all candidates will be considered without distinction of race, color, gender, age, sexual orientation, religion, origin, marital status, citizenship, or disability.