Pierre E.

Program Manager Clinical Trial Manufacturing @Catalent

Key Achievements & Responsibilities:• Designed and implemented a custom program management framework for each project, embedding industry best practices and a proactive risk mitigation approach. This initiative increased project efficiency, improved issue resolution speed, and ensured operational continuity during complex transitions • Spearheaded the stabilization and transition of a multi-project program supporting the manufacturing of high-quality Fill & Finish pharmaceutical products for clinical trials, collaborating with cross-functional teams in R&D, manufacturing, and clinical operations • Developed tailored transition strategies to optimize resource allocation, clarify team roles, and streamline communication, resulting in uninterrupted project momentum and successful handover to new operational owners• Proactively identified and mitigated risks by establishing clear responsibilities, regular risk reviews, and contingency plans, which minimized delays and ensured achievement of key milestones aligned with strategic goals • Oversaw complex logistics and cold chain management for clinical supply, coordinating shipment and storage of clinical batches under stringent temperature controls (from -80°C to 2–8°C), and validated aseptic processes through Media Fill Tests (MFT) • Fostered a culture of continuous improvement and feedback, leading regular project reviews and integrating lessons learned to further refine program management practices and drive ongoing performance gainsImpact:• Increased project efficiency and reduced risk-related disruptions across all clinical trial manufacturing projects.• Maintained full GMP compliance and product quality standards throughout all phases of clinical manufacturing and handover.• Enhanced cross-departmental collaboration, resulting in greater stakeholder engagement and satisfaction.