Head of Biologic Drug Substance - Process & Analytical Development

Experteer Overview

As 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.

Retribuzione / Benefits

• Lead Drug Substance Process & Analytical Development activities and set strategic direction.
• Deliver integrated development plans for early and late-stage biologics on time and within budget.
• Design and optimize robust, scalable biopharmaceutical manufacturing processes.
• Ensure compliance with global CMC regulations and evolving industry standards.
• Collaborate with Clinical, QA, Regulatory Affairs, Outsourcing, Operations, and Preclinical teams for seamless program execution.
• Manage CDMO interactions, external work packages, and technology transfer to commercial manufacturing.
• Drive innovation, apply QbD principles, and advance control strategies and validation plans.
• Lead CMC contributions for regulatory submissions and engage with health authorities.

Responsabilità

• At least 10 years in biopharmaceutical drug substance process development with leadership in complex biologics CMC programs.
• Strong knowledge of FDA, EMA, ICH and global CMC guidelines; track record translating regulatory expectations into practice.
• Experience managing CDMO partnerships and external development packages.
• Background in scientific due diligence for technologies and pipeline assets.
• Advanced analytical and problem-solving skills for data-driven decisions.
• Proven leadership and excellent communication across organizational levels.
• Advanced scientific degree (Ph.D. or M.Sc.) preferred; Bachelor’s considered.
• Experience with technology transfer, scale-up, and readiness for commercial manufacturing.
• Experience applying QbD and lifecycle management; capable of executive-level presentations.
• Willingness to travel domestically and internationally; team-building experience.

Requisiti fondamentali

• comprehensive healthcare programs
• work-life balance initiatives
• relocation support
• competitive salary with bonuses
• flexible working arrangements
• remote work options