Scientist II, Biologics Analytical Development (Fully Onsite)

AbbVie•Irvine, CA

1d•Onsite

About The Position

AbbVie’s department develops analytical methods for the analysis and characterization of biologics in CMC development. The Scientist develops bioassays and functional assays, including complex assays that improve understanding of kinetics and mechanisms of action. The role independently plans experimental work and performs multiple analytical methods to support biologics projects, while maintaining a productive, collaborative laboratory environment consistent with regulatory and company expectations. The position may also support biologics process development, formulation development, and stability studies. It involves generating, compiling, and evaluating data for technical reports supporting regulatory filings for new and currently marketed biological products, and may include writing report sections, methods, and operational SOPs. The role requires working in areas requiring select-agent access, including Biosafety Level 2 laboratories, and complying with applicable federal regulations and AbbVie policies.

Requirements

Bachelor’s degree or equivalent education with typically 7 or more years of experience, or a 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 related to 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 collaborate in a cross-functional team environment and manage multiple activities with appropriate guidance.
Ability to comply with requirements for work involving select agents and Biosafety Level 2 laboratories.

Nice To Haves

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

Responsibilities

Support development of phase-appropriate methods for biologics development programs.
Develop and validate analytical methods for the analysis and characterization of biopharmaceuticals.
Create written procedures and protocols.
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 platforms.
Support development of assays assessing biological activity, potency, mechanism of action, and relevant product attributes.
Participate on cross-functional teams within Biologics Development and support external departments.
Share scientific expertise and collaborate with the team to formulate 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 the project stage.
Maintain current knowledge of relevant scientific and technical literature and identify necessary equipment for state-of-the-art analytical methods.
Independently plan experimental work and perform analytical methods to support biologics projects.
Generate, compile, and evaluate data for technical reports supporting regulatory filings.
Support biologics process development, formulation development, and stability studies as a secondary priority.
Comply with AbbVie internal requirements and applicable regulatory requirements, including those governing select-agent access and Biosafety Level 2 laboratories.