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

About the role

The Biologics CMC Development team at AbbVie is seeking a highly motivated Senior Scientist II to join the Downstream Development team as a Scale-Up Laboratory Purification Leader. This role is best suited for someone who thrives in close partnership with scientists, engineers, and manufacturing teams.

Responsibilities

• 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.
• 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.
• 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.

Qualifications

• 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.
• 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.
• Strong written and verbal communication skills, including technical writing and scientific data presentation.
• Proven ability to troubleshoot equipment issues and work effectively with vendors on repairs, reliability improvements, and technical feedback.
• Strong understanding of biochemistry and bioprocess engineering principles relevant to downstream development and scale-up.
• Strong attention to detail and documentation practices.

Preferred

• Experience leading or overseeing a downstream scale-up laboratory or comparable technical development function.
• Hands-on experience supporting transfer of purification processes to pilot-scale, GMP manufacturing, or external CDMOs.
• Experience with monoclonal antibodies, bispecifics, or other complex biologic modalities across multiple scales.
• Experience advancing platform purification strategies or implementing next-generation technologies to improve robustness, cost, and efficiency.
• Knowledge of statistical tools and data analysis approaches that support process understanding and scale-up decisions.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs.