Pharmaceutical Development Manager - External Operations
hace 4 días
Azuqueca de Henares
In a nutshell Position: Pharmaceutical Development Manager - External Operations Location: Azuqueca de Henares Experience: More than 5 years in the development of the position and duties described Want to know more? 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. INSUD PHARMA'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 R&D 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. What are we looking for? We are recruiting a Pharmaceutical Development Manager – External Operations to join the R&D team at one of our plants located in Azuqueca de Henares. The challenge! As Pharmaceutical Development Manager - External Operations, you will lead, coordinate and supervise pharmaceutical development projects carried out at Insud Pharma Group's 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 at Insud Pharma Group 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, engagement 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 (Liconsa), 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. What do you need? • Higher 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 solid and semi-solid oral forms; 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., • Willingness to travel internationally to external sites and collaborating organisations as needed., • Passion for quality, patient safety, and making a difference in global health. Our benefits! ⏰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. 📜Permanent contract. 💸Attractive salary package. 🥼 Life and accident insurance. 🥼 Co-payment for voluntary health insurance. 💸Benefits and Savings Club. 📈Development plans, internal mobility policy. ⭐And much more! COMMITMENT TO EQUAL OPPORTUNITIES The InsudPharma group is aware that business management must be in line with the needs and demands of society, and therefore is committed to equal opportunities and treatment between men and women, as set out in current legislation on the matter -Organic Law 3/2007, and we do not discriminate against anyone on the basis of ethnicity, religion, age, sex, nationality, marital status, emotional or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
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