Principal Scientist I, Biologics Analytical R&D (External Programs)

Role: Senior analytical lead within AbbVie Biologics ARD, responsible for driving analytical development for biologic therapeutics (mAbs, ADCs, fusion proteins) from early development through clinical proof of concept. Responsibilities include formulating analytical strategies, overseeing method development, validation, and transfer, and supporting stability, release, and comparability studies. The role involves collaboration with internal teams and external laboratories to ensure timely execution, interpretation of complex data, and authoring technical/regulatory documentation. Key contributions include establishing product control strategies, driving data-driven process understanding, and supporting regulatory submissions. Qualifications: MS with 12+ years or PhD with 6+ years in Chemistry, Biochemistry, or Biology, with extensive experience in pharmaceutical analytical labs, especially in biologics. Must have strong expertise in protein chromatography (SEC, IEX, HIC), capillary electrophoresis, and separation techniques. Preferred skills include project management, proficiency with laboratory systems (LIMS, CDS, ELN), and statistical methods such as DOE. High-value biopharma specifics: focus on biologics development, early-stage clinical support, and analytical method development for complex protein therapeutics. The position requires strong cross-functional collaboration, scientific excellence, and leadership, with a seniority level appropriate to extensive hands-on experience in biologic analytical development.