Descripción de la oferta
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 / Beneficiosflexible working modelvolunteering activitiesdevelopment & learning opportunitiesremuneration and benefit customizationphysical, emotional and financial wellbeing support
ResponsabilidadesLead and develop the Analytical Development team, fostering excellence and continuous improvementSteer analytical drug development across all stages (method development, validation, transfer) for multiple programsPlan, prioritize, and allocate resources to ensure timely delivery and project alignmentProvide 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 QAPromote 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 inputCollaborate with Regulatory Affairs, Quality, Manufacturing, Formulation Development and external stakeholdersMaintain laboratory facilities and equipment, ensuring qualification, calibration, and trainingEngage in cross-functional interactions to enable successful development and project execution
Requisitos principalesAdvanced degree in Pharmaceutical Sciences, Chemistry, Analytical Chemistry or related scientific disciplineExtensive Analytical Development experience in the pharmaceutical industry (early to late development)Proven leadership of scientific teams in Analytical or Pharmaceutical DevelopmentStrong background in development of solid oral dosage forms; experience with liquids, suspensions, or injectables valuedSolid understanding of GMP and regulatory requirements; experience with EMA, FDA interactions and submissionsExperience working in cross-functional teams and managing multiple development programsEmpathyHumilityCuriosityHPLCUHPLCLC-MS/MS
