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Pharmaceutical development manager (gusendos de los oteros)

Gusendos de los Oteros
Solutions Driven
Publicada el 27 marzo
Descripción

As Manager of Pharmaceutical Development – External Operations, you will lead, coordinate and supervise pharmaceutical development projects carried out at company sites outside Spain and with external partners.Your mission: to ensure the highest quality development and smooth technology transfer of solid oral and semi-solid dosage forms from external centres to our flagship plant in Spain, driving the success of the portfolio in multiple markets.Specific responsibilities:Provide strategic oversight of R&D; projects developed oorganization plants outside Spain and through external partners such as CDMOs worldwide, primarily in solid oral and semi-solid dosage forms.Manage all formulation, analytical and process development activities, from pre-formulation to industrialisation, ensuring overall compliance with corporate objectives, regulatory requirements and project deadlines.Supervise, guide and inspire a high-performance team; define annual objectives aligned with the company's strategy and foster a culture of innovation, involvement and continuous improvement.Review, approve and validate project documentation (development, analytical, regulatory, clinical) prepared by international and third-party teams, ensuring the most rigorous standards for regulatory submission and audit readiness.Drive seamless technology transfer and product scaling, ensuring robust implementation in Spanish production, including plant preparation, process reproducibility, equipment qualification and comprehensive technical documentation.Align projects and coordinate effectively with general cross-functional teams: Clinical Development, Production, Regulatory Affairs, Business Development, Supply Chain, Quality, among others.Propose optimal resource allocation and lead change initiatives to enhance capacity, efficiency, and adoption of best practices in internal and external networks.Monitor KPIs for deadline compliance, document quality, process reproducibility, and submission/approval rat

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