03 ago
|
Ferrer
|
Barcelona
Experteer Overview
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In this role you will safeguard the scientific integrity and regulatory alignment of Ferrer’s Ru0026amp;D portfolio, coordinating across Quality, Regulatory Affairs, and Manufacturing. You will lead nitrosamine risk oversight and contribute to robust decision-making that maximizes the impact of Ru0026amp;D investments. You’ll partner to maintain lifecycle management and ensure compliance with EMA and FDA guidelines. This role offers the chance to influence cross-functional programs and advance strategic initiatives in a hybrid work setting.
Compensaciones / Beneficios
• Lead end-to-end nitrosamine risk assessment and mitigation across the portfolio, ensuring integral regulatory compliance.
• Collaborate with Quality, Regulatory Affairs, and Manufacturing to maintain control strategies and lifecycle plans.
• Provide scientific support for investigation of complex product/process issues, contribute to CAPAs, and facilitate cross-functional resolution.
• Coordinate and track Ru0026D programs, align timelines and milestones with strategic objectives, and enable efficient execution.
• Develop robust scientific justifications to support Ru0026D projects within strategic frameworks and prepare required documentation for external programs.
• Collaborate with Finance, Regulatory, Scientific, and Strategy teams to ensure robust inputs for investment justification and reporting.
• Act as a transversal role across departments to bridge scientific and business perspectives and maximize Ru0026D value.
Responsabilidades
• Degree in Chemistry, Pharmacy, Biochemistry, or a related field.
• Minimum of 5 years of pharmaceutical industry experience.
• Hands-on laboratory experience ('white coat' background) is essential.
• Strong knowledge of late-stage pharmaceutical development and/or quality processes.
• Experience in risk management; nitrosamines knowledge is highly desirable.
• Familiarity with EMA and FDA regulatory requirements.
• Experience in industrial troubleshooting and problem-solving.
• Experience in pharmaceutical manufacturing environments (API and/or Drug Product) is highly desirable. xqbhyrx
• Strong understanding of Quality Risk Management principles (ICH Q9).
• Experience in managing Ru0026D programs.
Requisitos principales
• volunteering opportunities
• versátil working model
• development and learning opportunities
• wellbeing benefits
• remuneration customization
• hybrid/office collaboration
📌 R&D Program Manager (Barcelona)
🏢 Ferrer
📍 Barcelona