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

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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 stron