19 sep
|
Jobrapido
|
Barcelona
19 sep
Jobrapido
Barcelona
Overview
A continuación, encontrará un desglose completo de todo lo que se requiere de los posibles candidatos, así como la forma de presentar su candidatura. Mucha suerte
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 / Incentivos
- 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, Qua
📌 SENIOR ANALYTICAL DEVELOPMENT MANAGER (Barcelona)
🏢 Jobrapido
📍 Barcelona