Overview

In this role you will lead analytical development activities for new chemical entities and solid dosage forms, guiding a multidisciplinary team to drive method development, validation, transfer, and regulatory-compliant delivery across preclinical to Phase III programs. You will align analytical strategy with development objectives, ensure quality and regulatory readiness, and partner with cross-functional teams to enable successful submissions. The role combines scientific leadership with hands-on expertise to shape development programs and lifecycle management. You will be pivotal in applying QbD principles and ensuring robust, compliant analytics that support general regulatory filings.

Compensaciones / Beneficios

- flexible working model
- volunteering activities
- development & learning opportunities
- remuneration and benefit customization
- physical, emotional and financial wellbeing support

Responsabilidades

- Lead and develop the Analytical Development team, fostering excellence and continuous improvement
- Steer analytical drug development across all stages (method development, validation, transfer) for multiple programs
- Plan, prioritize, and allocate resources to ensure timely delivery and project alignment
- Provide hands-on expertise in analytical methods (HPLC, UHPLC, LC-MS/MS, GC, UV-Vis, FTIR) and physicochemical characterization (XRPD, DSC, TGA, DVS, particle size, microscopy, Karl Fischer)




- Ensure regulatory compliance (ICH Q14, Q2(R2), Q8, Q9; GMP and data integrity) and support lifecycle management and QA
- Promote Quality by Design and analytical lifecycle thinking (ATP, risk assessment, robustness, transfer)
- Draft, review and approve Analytical Development documentation; support regulatory submissions (EU/US) and dossier input
- Collaborate with Regulatory Affairs, Quality, Manufacturing, Formulation Development and external stakeholders
- Maintain laboratory facilities and equipment, ensuring qualification, calibration, and training
- Engage in cross-functional interactions to enable successful development and project execution

Requisitos principales

- Advanced degree in Pharmaceutical Sciences, Chemistry, Analytical Chemistry or related scientific discipline
- Extensive Analytical Development experience in the pharmaceutical industry (early to late development)
- Proven leadership of scientific teams in Analytical or Pharmaceutical Development
- Strong background in development of solid oral dosage forms; experience with liquids, suspensions, or injectables valued
- Solid understanding of GMP and regulatory requirements; experience with EMA, FDA interactions and submissions
- Experience working in cross-functional teams and managing multiple development programs

- Empathy
- Humility
- Curiosity
- HPLC
- UHPLC
- LC-MS/MS

📌 SENIOR ANALYTICAL DEVELOPMENT MANAGER - barcelona
🏢 Ferrer
📍 Barcelona