SENIOR ANALYTICAL DEVELOPMENT MANAGER (Barcelona)

SENIOR ANALYTICAL DEVELOPMENT MANAGER (Barcelona)

04 sep
|
Ferrer
|
Barcelona

04 sep

Ferrer

Barcelona

Experteer 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 / Incentivos
• 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

Responsabilidades
• 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

Requisitos principales
• flexible working model
• volunteering activities
• development u0026 learning opportunities
• remuneration and benefit customization
• physical, emotional and financial wellbeing support

📌 SENIOR ANALYTICAL DEVELOPMENT MANAGER (Barcelona)
🏢 Ferrer
📍 Barcelona

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