Descripción de la oferta
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
Establish a robust governance process of CMO, including capacity assessment, KPI measure and Supply Planning to support S&OP process.
Identify risks and define/track actions together with stakeholders to mitigate the risks.
Generate information, measurement and follow up performance indicators in Drug Product, including Lead Times, Schedule adherence, and others to support proper inventory management.
Lead initiatives to improve supply chain efficiency, cost-effectiveness, and quality.
Identify opportunities for automation and data-driven decision-making to enhance supply chain performance.
REQUIREMENTS AND PERSONAL SKILLS
Education: University Degree and preferably Master in Supply Chain. A degree in Pharmacy or similar is an asset.
Languages: Fluent Spanish and English, knowledge of other languages will be an asset.
Experience (years/area): +2 years of experience in a similar position.
Specific Knowledge: Manufacturing Support activities, GMP and SHE regulations. Strong Customer focus and relationship building. Basic knowledge in medication registries. Logistics knowledge in the pharmaceutical industry and SAP R3 and APO.
Travels: Willingness to travel.
Personal skills: Good organizational and communication skills, accuracy and reliability. Good interaction and team working capacity, ability to multi-tasks, demonstrated strong organizational skills and ability to independently prioritize work, attention to detail, excellent communication skills, accuracy, flexibility and openness to changes. Keeping focus in changing environments and experience in conflict resolution and negotiation 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.
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