Scientist II, Biologics Analytical Development (Fully Onsite)

AbbVie•Irvine, CA

1d•$84,500 - $162,000•Onsite

About The Position

AbbVie’s Biologics Analytical Development department develops analytical methods for the analysis and characterization of biologics in CMC development. The Scientist develops bioassays and functional assays, with particular focus on early development of complex bioassays to improve understanding of kinetics and mechanisms of action. The role primarily involves independently planning experimental work and carrying out multiple analytical methods to support biologics projects, based on departmental needs, while maintaining a productive and collaborative laboratory environment consistent with regulatory and company expectations. As a secondary priority, the role may support biologics process development, formulation development, and stability studies. This includes independently generating, compiling, and evaluating data for technical reports supporting regulatory filings for new and currently marketed biological products, and contributing to technical reports, methods, and operational SOPs. The scientist develops and validates analytical methods, supports method transfer and qualification, and collaborates with cross-functional teams. The position involves work in areas requiring access to select agents, including Biosafety Level 2 laboratories. All work must comply with applicable federal regulations and AbbVie requirements, including policies related to ethics, environmental health and safety, finance, human resources, and general business conduct.

Requirements

Bachelor’s degree or equivalent education with typically 7 or more years of experience, or master’s degree or equivalent education with typically 5 or more years of experience.
Advanced knowledge and experience developing, validating, and transferring methods for biologics, including quantitative ELISA, potency assays, enzyme activity assays, and other bioassays.
Solid understanding of methods and procedures for production and characterization of biopharmaceuticals in a regulated environment.
Understanding of CMC development strategy for biologics drugs.
Understanding of analytical method development, qualification, validation, and transfer principles.
Ability to analyze, interpret, document, and communicate experimental data effectively.
Ability to work collaboratively in a cross-functional team environment and manage multiple activities with appropriate guidance.
Ability to comply with applicable federal regulations and AbbVie internal requirements for work involving select agents and Biosafety Level 2 laboratories.

Nice To Haves

Familiarity with cell-based assays, molecular biology techniques, or protein characterization methods.

Responsibilities

Support development of phase-appropriate methods for biologics development programs.
Develop and validate analytical methods for analysis and characterization of biopharmaceuticals; create written procedures and protocols; and transfer, qualify, or validate methods as needed.
Use routine and specialized analytical techniques to characterize and quantify biopharmaceuticals, including assay development for protein mass determination.
Develop and optimize bioassays and functional assays, including ELISA, TR-FRET, AlphaLISA, and related assay platforms.
Support development of assays assessing biological activity, potency, mechanism of action, and relevant product attributes.
Participate in cross-functional teams within Biologics Development and support external departments; share scientific expertise and collaborate on solutions to problems.
Develop protocols and SOPs, train staff, and maintain the laboratory according to departmental and company requirements.
Understand, document, and adjust Quality Systems to match project stage, such as pre-development or development.
Maintain current knowledge of relevant scientific and technical literature and support development of state-of-the-art analytical methods, including acquisition of necessary equipment.
Independently plan experimental work and conduct multiple analytical methods to support biologics projects.
As a secondary priority, support biologics process development, formulation development, and stability studies; generate, compile, and evaluate data for technical reports supporting regulatory filings.
Support writing sections or subsections of technical reports, methods, and operational SOPs.
Conduct work involving select agents and Biosafety Level 2 laboratories in compliance with federal regulations and AbbVie requirements.