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Pharmaceutical development manager - external operations

Azuqueca de Henares
Chemo
Publicada el 25 octubre
Descripción

Pb In a nutshell /b /p p Position: Pharmaceutical Development Manager - External Operations /pp Location: Azuqueca de Henares /pp Experience: More than 5 years in the development of the position and duties described /p pb Want to know more? /b /p p INSUD PHARMA operates across the entire pharmaceutical value chain, providing expertise and experience in scientific research, development, manufacturing, sales and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs) and branded pharmaceutical products, with added value for human and animal health. /p p INSUD PHARMA#39;s activity is organised into three synergistic business areas: Industrial (Chemo), Branded (Exeltis) and Biotech (mAbxience), with more than 9,000 professionals in over 50 countries, 20 state-of-the-art facilities, 15 specialised RD centres, 12 commercial offices and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries around the world. INSUD PHARMA believes in innovation and sustainable development. /p pb What are we looking for? /b /p p We are recruiting a Pharmaceutical Development Manager – External Operations to join the RD team at one of our plants located in Azuqueca de Henares. /p pb The challenge! /b /p p As Pharmaceutical Development Manager - External Operations, you will lead, coordinate and supervise pharmaceutical development projects carried out at Insud Pharma Group#39;s sites outside Spain and with external partners. /p p 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. /p pb Specific responsibilities /b /p ulli Provide strategic oversight of RD projects developed at Insud Pharma Group plants outside Spain and through external partners such as CDMOs worldwide, primarily in solid oral and semi-solid dosage forms. /li /ul ulli Manage all formulation, analytical and process development activities, from pre-formulation to industrialisation, ensuring overall compliance with corporate objectives, regulatory requirements and project deadlines. /li /ul ulli Supervise, guide and inspire a high-performance team; define annual objectives aligned with the company#39;s strategy and foster a culture of innovation, engagement and continuous improvement. /li /ul ulli 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. /li /ul ulli Drive seamless technology transfer and product scaling, ensuring robust implementation in Spanish production (Liconsa), including plant preparation, process reproducibility, equipment qualification and comprehensive technical documentation. /li /ul ulli Align projects and coordinate effectively with global cross-functional teams: Clinical Development, Production, Regulatory Affairs, Business Development, Supply Chain, Quality, among others. /li /ul ulli Propose optimal resource allocation and lead change initiatives to enhance capacity, efficiency and adoption of best practices in internal and external networks. /li /ul ulli Monitor KPIs for deadline compliance, document quality, process reproducibility and submission/approval rates; proactively address project risks and leverage new opportunities. /li /ul ulli 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. /li /ul ulli Support business audits, budget planning, and talent development; play a key role in organisational and cultural integration. /li /ul pb What do you need? /b /p ulli Higher degree in Pharmacy, Pharmaceutical Sciences, Chemistry or related field. /lili≥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. /lili Solid knowledge of formulation, analytical and process development—especially for solid and semi-solid oral forms; practical experience in scale-up, technology transfer and regulatory submissions (FDA/EMA and others) required. /lili Fluency in English (spoken/written); Spanish and/or other languages will be a significant advantage. /lili Proven leadership of multidisciplinary and multicultural teams; able to align diverse stakeholders in a highly dynamic and matrix environment. /lili Excellent project management, negotiation, and interpersonal skills; proven track record in problem solving, innovation, and meeting objectives on time and within budget. /lili Willingness to travel internationally to external sites and collaborating organisations as needed. /lili Passion for quality, patient safety, and making a difference in global health. /li /ul pb Our benefits! /b /p p⏰Monday to Friday working hours, with flexible start times between 8:00 a.m. and 9:30 a.m. and finish times depending on start time, from 4:30 p.m. onwards. /pp Permanent contract. /pp Attractive salary package. /p

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