Scientist II, Biologics Analytical Development (Fully Onsite) Full-time NEW

AbbVie Scientist Position

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience – and products and services in our Allergan Aesthetics portfolio.

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.

Where We Work

Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.