Support development of phase appropriate methods to support biologics development programs.

Execute the development and validation of analytical methods for the analysis and characterization of biopharmaceuticals. Create written procedures and protocols. Transfer, qualify or validate methods as needed.

Apply 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 the development of assays that assess biological activity, potency, mechanism of action, and relevant product attributes.

Actively participate on cross-functional teams within Biologics Development and provide support to external departments. Openly share scientific expertise and collaboratively help the team to formulate rational solutions to problems.

Develop protocols and SOPs, train staff and maintain the laboratory consistent with departmental and company requirements. Understand, document, and adjust Quality Systems to match the project stage (e.g. pre-development or development).

Maintain a good and current knowledge of scientific and technical literature pertinent to the project and necessary for development of state-of-the-art analytical methods, including the acquisition of necessary equipment.

BS or equivalent education with typically 7+ years of experience or MS or equivalent education with typically 5+ or more years of experience, is required.

Advanced knowledge and experience in developing, validating and transferring methods for biologics, including qELISA (quantitative), Potency Assays, enzyme activity assays and other bioassays.

A solid understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.

Understanding in CMC development strategy of biologics drugs is expected.

Scientist II, Biologics Analytical Development (Fully Onsite)

Responsibilities

Benefits

Company

AbbVie

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