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Overview: We are seeking a highly experienced CMC Process Validation professional to support a niche project within the animal health sector, focused on sterile manufacturing. This role requires a strategic and hands-on expert who can lead and execute CMC-related activities, particularly around process validation and regulatory documentation. This is a high-priority assignment with active stakeholder engagement and a strong likelihood of progression for the right candidate. The project is entering a critical phase, and your expertise will be instrumental in driving it forward. Key Responsibilities: • Lead the preparation and consolidation of CMC documentation to support regulatory filings, • Develop and execute process validation protocols in alignment with regulatory expectations, • Translate complex CMC data into clear, compliant reports, • Collaborate cross-functionally to gather and interpret project information, • Provide strategic input while remaining operationally hands-on throughout the project lifecycle Requirements: • Proven expertise in CMC process validation, ideally at a Manager, Director, or SME level, • Experience in sterile manufacturing is highly preferred, • Fluency in French and English is essential, • Strong understanding of regulatory requirements and documentation standards, • Ability to work onsite in Segre, France at least 3 days per week, • Comfortable operating in both strategic and executional capacities Ideal Candidate Profile: You are a seasoned CMC professional with a deep understanding of sterile processes and regulatory frameworks. You thrive in dynamic environments, can quickly integrate into cross-functional teams, and are adept at transforming technical data into actionable insights. Your bilingual fluency and hands-on approach make you a valuable asset in high-stakes projects.