Scientist II, Biologics Analytical Development (Fully Onsite)

Job Description

Our department develops analytical methods for the analysis and characterization of biologics in CMC development. We are looking for an experienced and accomplished Scientist with a track record of developing bioassays and functional assays. In particular, the scientist will work on early development of complex bioassays to improve our understanding of the kinetics and mechanisms of action.

The individual will primarily work independently to plan experimental work and carry out multiple analytical methods to support AbbVie biologics projects depending on departmental needs. Maintains a productive and collaborative laboratory environment consistent with regulatory and company expectations.

The individual may also support as a secondary priority biologics process development, formulation development, and stability studies. This includes independently generating, compiling, and evaluating data for technical reports to support regulatory filings for new and currently marketed biological products. The individual may also support writing sections or subsections of technical reports, method and/or operational SOPs. The individual independently carries out multiple analytical methods to support AbbVie biologics projects depending on departmental needs. Maintains a productive and collaborative laboratory environment consistent with regulatory and company expectations.

The position requires the individual to work with and in areas requiring select agents access (i.e. Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

Responsibilities

• 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.

Qualifications

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

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

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