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

Senior Scientist II, Downstream 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

Qualifications

• 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 writing and scientific data presentation
• Ability to independently design, execute, and interpret experiments to solve complex technical problems
• 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

Where We Work

Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.