Principal Research Scientist II, Analytical Lead, R&D
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About the role
AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for CMC analytical development of AbbVie's pipeline of innovative therapeutic biologic products. We are a world-class team of scientists and leaders united by a shared mission to drive the advancement of industry-leading analytical capabilities and meaningfully contribute to advancing AbbVie's pipeline of innovative medicines. The Biologics ARD team at the AbbVie Bay Area site in South San Francisco has a long and rich history of biologics development. Located in a state-of-the-art facility housing end-to-end CMC development capabilities, the team works collaboratively to advance novel biologic therapeutics - including multi-specifics, ADCs, antibodies, and novel modalities - into first-in-human clinical development and through to clinical proof of concept. Careers in AbbVie Biologics ARD provide unique opportunities to work with cross-functional and global teams to drive exceptional science and innovative product development strategies. Role Summary The Analytical Lead owns the analytical development strategy and deliverables for assigned biologic programs and serves as the primary analytical point of contact on the CMC development teams for these programs. Deliverables span product control strategies, CQA assessments, characterization and comparability studies, release and stability packages, and regulatory submission content. The Analytical Lead is responsible for coordinating method development, validation, transfer, and clinical supply testing across internal lab teams, Quality Control, and external contract labs. The role operates within a cross-functional, on-site environment supporting a portfolio that includes multi-specifics, antibodies, ADCs, and novel modalities.