Descripción de la oferta
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 responsibilitiesProvide strategic oversight of R&D projects developed in organisation 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 global 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 rates; proactively address project risks and leverage new opportunities.Present project status and strategic recommendations to senior management and global leadership, acting as a visible benchmark for external innovation, excellence, and patient-centred value.Support business audits, budget planning, and talent development; play a key role in organisational and cultural integration.QualificationsHigher degree in Pharmacy, Pharmaceutical Sciences, Chemistry or related field.≥5 years of experience in pharmaceutical development, with proven experience in managing international projects and with third parties (/CDMOs); experience in generic drug development highly valued.Solid knowledge of formulation, analytical and process development—especially for semi-solid and solid oral forms (most solids); practical experience in scale-up, technology transfer and regulatory submissions (FDA/EMA and others) required.Fluency in English (spoken/written); Spanish and/or other languages will be a significant advantage.Proven leadership of multidisciplinary and multicultural teams; able to align diverse stakeholders in a highly dynamic and matrix environment.Excellent project management, negotiation and interpersonal skills; proven track record in problem solving, innovation and meeting objectives on time and within budget. xqbhyrxWillingness to travel internationally to external sites and collaborating organisations as necessary.
#J-18808-Ljbffr
