Ph3Experteer Overview /h3pAs Head of Biologic Drug Substance Process and Analytical Development, you will define and drive the CMC strategy for biologics from research to launch. You will lead the Drug Substance process and analytical development, ensuring compliance, scaling, and technical excellence. You will partner across Clinical, Quality, Regulatory, and Operations to deliver high-quality programs and seamless tech transfer. This role shapes the biologics portfolio and contributes to Chiesi’s mission of sustainable, patient-focused innovation. You’ll operate in a global context, influencing regulatory readiness and strategic decisions. /ph3Retribuzione / Benefits /h3ulliLead Drug Substance Process Analytical Development activities and set strategic direction. /liliDeliver integrated development plans for early and late-stage biologics on time and within budget. /liliDesign and optimize robust, scalable biopharmaceutical manufacturing processes. /liliEnsure compliance with global CMC regulations and evolving industry standards. /liliCollaborate with Clinical, QA, Regulatory Affairs, Outsourcing, Operations, and Preclinical teams for seamless program execution. /liliManage CDMO interactions, external work packages, and technology transfer to commercial manufacturing. /liliDrive innovation, apply QbD principles, and advance control strategies and validation plans. /liliLead CMC contributions for regulatory submissions and engage with health authorities. /li /ulh3Responsabilità /h3ulliAt least 10 years in biopharmaceutical drug substance process development with leadership in complex biologics CMC programs. /liliStrong knowledge of FDA, EMA, ICH and global CMC guidelines; track record translating regulatory expectations into practice. /liliExperience managing CDMO partnerships and external development packages. /liliBackground in scientific due diligence for technologies and pipeline assets. /liliAdvanced analytical and problem-solving skills for data-driven decisions. /liliProven leadership and excellent communication across organizational levels. /liliAdvanced scientific degree (Ph.D. or M.Sc.) preferred; Bachelor’s considered. /liliExperience with technology transfer, scale-up, and readiness for commercial manufacturing. /liliExperience applying QbD and lifecycle management; capable of executive-level presentations. /liliWillingness to travel domestically and internationally; team-building experience. /li /ulh3Requisiti fondamentali /h3ullicomprehensive healthcare programs /liliwork-life balance initiatives /lilirelocation support /lilicompetitive salary with bonuses /liliflexible working arrangements /liliremote work options /li /ul /p #J-18808-Ljbffr