Biologics Process Expert

Job Title: Biologics Process Expert GCL : D Introduction to role Are you ready to apply deep process understanding and digital innovation to make every biologic shipment a reliable bridge from lab to patient? Do you thrive at the intersection of stress and shear science, modeling, and practical operations, and want to see your decisions protect product quality and patient supply at scale? As a specialist in biologics processing, you will provide technical leadership in drug substance and drug product shipping validation across the portfolio, from development through commercial supply. You will design and deliver robust validation strategies that align transport conditions with product quality, stability, and supply requirements—partnering closely with formulation, analytical, manufacturing, packaging, supply chain, quality, and regulatory teams. Beyond shipping validation, you will elevate biologics process science by demonstrating artificial intelligence, advanced analytics, and predictive modeling to reimagine how we design studies, interpret data, and manage knowledge. Your work will standardize, accelerate, and strengthen end-to-end practices, building confidence in every shipment and every dose. Accountabilities • Shipping Validation Leadership: Lead development and execution of DS and DP shipping validation strategies across development and commercial stages to ensure product integrity and continuous patient availability. • Study Design and Analysis: Design, implement, interpret, and document shipping studies covering temperature excursions, vibration, shock, handling stress, freeze-thaw exposure, agitation, and shear; translate insights into clear acceptance criteria and practical guidance. • Apply expertise in protein and biologics degradation mechanisms, including aggregation, particle formation, denaturation, potency loss, and container closure interactions, related to forces and shear effects to define robust controls and mitigations. • Predictive Modeling and AI: Use and advance mechanistic, statistical, and digital models; drive AI-enabled tools and advanced analytics to assess transport risk, optimize validation designs, and accelerate decision-making. • Digital approaches: Automate, standardize, and simplify experimental building, data analysis, and technical reporting through digital and AI-enabled methods to increase speed, reproducibility, and clarity. • Innovation Scouting: Identify, evaluate, and implement innovative shipping technologies, packaging configurations, lane strategies, monitoring tools, and distribution models to improve protection, efficiency, sustainability, and reliability. • multi-functional Collaboration: Partner with formulation scientists, process engineers, device and packaging teams, supply chain, manufacturing, quality, analytical sciences, regulatory, and external logistics providers to define requirements, acceptance criteria, and implementation plans. • Compliance and Standards: Ensure alignment with ISTA standards, good distribution practices, and applicable regulatory expectations for transportation validation. • Assist with deviation investigations, perform root cause analysis, and evaluate hazards linked to shipping and handling. Lead or support collaborative feasibility and hazard reviews for new solutions. • Documentation Excellence: Author and review protocols, reports, risk assessments, comparability assessments, and regulatory support documentation to a high standard. • Process Science Contribution: Contribute to the understanding and mitigation of process-related stresses across mixing, pumping, filtration, filling, transfer, storage, and other unit operations where stresses influence stability and performance. • Capability Building and Continuous Improvement: S