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 integral 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.
Qualifications:
- 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 semi- solid and solid oral forms (most solids);
practical experience inscale-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 necessary.