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: Share guidelines, mentor colleagues, and help establish standards, frameworks, and digital tools; drive continuous improvement across end-to-end transportation and handling practices. • Business Translation: Partner with stake-holder functions to define business needs and translate them into technical assessment plans, including testing strategies, data interpretation, and recommendations for implementation. Essential Skills/Experience • Advanced-degree in chemical engineering, biochemical engineering, pharmaceutical sciences, biotechnology, biophysics, or related subject area. A Ph. D and/or a graduate degree or equivalent experience with 1-3 years is preferred • Understanding and experience in biologics process development, formulation development, manufacturing sciences, or technical operations, with strong exposure to shipping validation for DS and/or DP. • Demonstrated understanding and expertise in biologics stability and product quality impacts associated with mechanical stress, agitation, shear, vibration, shock, and temperature excursions. • Strong understanding of protein science and the impact of process and transport conditions on biologics attributes. • Knowledge of and/or experience with shipping validation study building, transportation risk assessments, and interpretation of complex technical data. • Understanding and/or working knowledge of ISTA standards and practical application in pharmaceutical or biologics transportation studies. • Understanding and/or experience applying modeling, simulation, statistics, or digital tools to process understanding or validation activities. • Experience using or implementing AI-enabled tools, advanced analytics, or data-driven approaches to improve scientific workflows, decision-making, or process performance. • Strong technical writing and documentation skills, with experience preparing high-quality reports and technical justifications. • Ability to work effectively across multidisciplinary, global teams and influence without direct authority. Desirable Skills/Experience • Experience in both data substance and data product operations, including interactions between upstream/downstream processing, formulation, fi