CMC Validation

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.

Location: Angers, FR

Posted Date: 8/29/2025