Senior Director

Overview

A commercial-stage biologics organisation undergoing significant expansion of its technical development and manufacturing capabilities. Following a series of strategic investments into both internal infrastructure and external manufacturing partnerships, the company is preparing for multiple lifecycle management programs, process improvements, and next-generation product launches across its portfolio.

Reporting directly to the Vice President of Technical Operations, the Senior Director of Process Development will lead a growing team responsible for process optimisation, scale-up, technology transfer and lifecycle management activities across a portfolio of commercial and late-stage biologic products.

• Lead all Process Development activities supporting commercial and late-stage biologics programs
• Drive process optimisation, yield improvements and manufacturing robustness initiatives
• Oversee scale-up and technology transfer activities into internal manufacturing sites and external CDMO partners
• Lead process characterization, validation strategy and continued process verification activities
• Build and mentor a high-performing Process Development organisation across upstream and downstream disciplines
• Partner closely with Manufacturing, MSAT, Quality and Regulatory teams to ensure commercial supply continuity
• Evaluate emerging technologies and manufacturing innovations to improve process performance and cost of goods
• Provide technical leadership during inspections, regulatory submissions and major manufacturing investigations

• PhD, MSc or equivalent industry experience in Chemical Engineering, Biochemistry or related field
• 12+ years of biologics process development experience
• Proven experience supporting commercial biologics manufacturing
• Strong expertise in process scale-up, technology transfer and validation
• Demonstrated leadership experience managing technical development teams
• Experience working with both internal manufacturing facilities and CDMO networks
• Strong understanding of GMP manufacturing and regulatory expectations
• Excellent communication and stakeholder management skills