The Biologics CMC Development team at AbbVie in the Bay Area has a long and rich history of biologics development. Now 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 complex biologic therapies, such as bi-specifics and novel modalities, to human clinical studies and eventual licensure. This Scientist I 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.

As a CMC purification development scientist, you will independently design, execute, and interpret experiments to develop robust, phase-appropriate purification processes for drug substance GMP production to enable human clinical studies and eventual licensure. This position is an onsite, lab-based role requiring close collaboration and daily face-to-face interactions with scientists.

Responsibilities

• Develop, optimize, and scale up purification processes for monoclonal antibodies, multi-specifics, antibody-like molecules, and other complex biologic candidates across early- and late-stage drug substance process development; independently design and execute experiments, interpret results, and recommend next steps. 
• Support transfer of purification processes to GMP manufacturing sites for clinical material production, including preparation of technical documentation.
• Evaluate novel, advanced bioprocess technologies that are in line with the group’s strategy 
• Plan and execute laboratory and scale-up activities efficiently, collaborating within the team and cross-functionally to meet project timelines and goals.
• Work with contract laboratories to plan and execute assigned viral clearance studies, interpret results, and contribute to technical documentation.
• Author technical reports and maintain complete, traceable experimental and batch records, including instrument and analytical data, in approved electronic systems; document results at execution and follow established procedures and timelines.
• Prepare and deliver technical presentations and group-meeting updates; critically evaluate experimental results, communicate recommendations, and promptly document and communicate significant deviations or unexpected results
• Follow applicable laboratory and scale-up facility safety procedures and standard operating procedures (SOPs), complete required training before performing assigned activities, and contribute to laboratory readiness through equipment maintenance, cleanliness, and inventory management