Senior Scientist II, Downstream Development (Scale-Up Laboratory Lead)

Job description

About AbbVie CMC Development The Biologics CMC Development team at AbbVie has a long and rich history of biologics development. Located in a new state of the art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing biologic therapies, such as monoclonal antibodies, bi-specifics and novel modalities, to human clinical studies and eventual licensure. This role is within a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20+ novel oncology drugs and successfully filed two BLAs. We are seeking a highly motivated Senior Scientist II to join the Downstream Development team as a Scale-Up Laboratory Purification Leader. In this role, you will lead laboratory-based scale-up activities to develop, optimize, and transfer robust, phase-appropriate downstream processes for biologic drug substance manufacturing. You will provide technical leadership across scale-up and technology transfer activities while helping advance next-generation purification platform capabilities. This role requires strong technical expertise in downstream development, scale-up and tech transfer, demonstrated leadership skills, and the ability to work effectively in a highly collaborative, team-based, matrixed environment. This position is an onsite laboratory-based role and is best suited for someone who thrives in close partnership with scientists, engineers, and manufacturing teams. Responsibilities include: • Lead downstream scale-up lab activities and non-GMP material generation to support CMC development, optimization, and transfer of purification processes for biologic candidates across development stages. • Maintain operational readiness of the scale-up lab, including equipment availability, workflow planning, consumables, and efficient activity scheduling • Serve as a subject matter expert and technical lead for downstream scale-up and technology transfer; collaborate with and provide technical guidance to project purification development representatives to support transfer to the scale-up lab and GMP manufacturing • Lead downstream technology transfer activities to internal manufacturing sites and external partners, including transfer package preparation, batch support, and resolution of scale-up or execution issues • Serve as an AKTA subject matter expert (AKTA Ready, AKTA Ready LX, AKTA Avant, AKTA Pure), including method development and execution using UNICORN software • Drive scientific understanding and execution of downstream unit operations, including resin- and membrane-based chromatography, filtration, viral clearance operations, high-concentration UF/DF, and formulation. • Provide hands-on leadership in large column packing (AxiChrom, QuickScale, BPG), buffer preparation, equipment setup, and unit operation execution • Develop and implement scale-up lab operational workflows, procedures and documentation to enable efficient, reliable, and compliant execution of downstream development activities • Design and execute scale-down and scale-up studies to build process understanding, assess robustness, and improve manufacturing readiness • Troubleshoot process and equipment issues efficiently; work closely with vendors to resolve problems and provide feedback to improve systems and workflows. • Identify and implement next-generation purification platform strategies and workflow improvements to enhance scalability, robustness, efficiency, and cost effectiveness • Partner effectively across a matrixed organization with upstream, analytical, drug product, manufacturing, and engineering teams • Mentor junior scientists and, where applicable, manage direct reports through strong planning, communication, and scientific judgment • Author and review technical reports, development summaries, transfer documentation, and regulatory support documents • Work efficiently and collaboratively to meet program milestones while maintaining high standards for safety, documentation, and data integrity • Promote a strong safety culture by ensuring scale-up lab activities, equipment use, and material handling practices are executed in accordance with site safety and compliance requirements Basic: • Degree in Chemical Engineering, Biochemistry, Chemistry, or other relevant scientific discipline with BS and typically 12+ years of experience, MS and typically 10+ years of experience, or PhD and typically 4+ years of experience • Significant experience in downstream/purification process development within a biologics CMC environment • Demonstrated expertise in process scale-up, scale-down model execution, and technology transfer • Must be an AKTA systems expert, including deep hands-on experience with UNICORN software • Hands-on experience operating large-scale TFF processes (hundreds of grams; e.g., Allegro, Cytiva, Repligen, or manually operated skids), packing 3–20 L columns with affinity and polishing resins, using single-use technologies (e.g., SUMs, pre-packed columns, AKTA flow kits, TFF flow kits), operating large-scale filtration processes including depth filtration, virus filtration, and chromatography membrane filtration, and executing large-volume formulations • Experience with large column packing, buffer preparation, equipment troubleshooting, and day-to-day laboratory execution • Proven ability to troubleshoot equipment issues and work effectively with vendors on repairs, reliability improvements, and technical feedback • Demonstrated leadership skills with ability to lead projects, influence decisions, and mentor others • Working knowledge of analytical methods such as HPLC, CE, UV-based quantitation, and impurity characterization used to support downstream development • Must work effectively in a team-based, highly collaborative, matrixed environment • Strong written and verbal communication skills, including technical wri