21 sep
|
Ferrer
|
Barcelona
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 global regulatory filings.
Compensaciones / Ventajas
- 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 trai
📌 SENIOR ANALYTICAL DEVELOPMENT MANAGER (Barcelona)
🏢 Ferrer
📍 Barcelona