Job Description:
The Analytical Development-Early-Stage group within Biologics ARD is responsible for support of programs that are preparing for FIH clinical studies. The team leads Stage 1 method development, optimization, and validation. In collaboration with cross-functional partners, the team supports early phase formulation and process development studies. Key deliverables include product control strategies informed by analytical data and method understanding; robust analytical methods suitable for commercial QC labs; comprehensive data packages that drive product and process understanding; clinical supplies release testing and stability studies to establish clinical product dating; substantial clinical trial application submission content.Responsibilities:Laboratory operational support for the group’s experimental development and testing activities.Complex solution preparation in a GxP environment.Laboratory balance checks and pH meter standardizations.Inventory/resource management (e.g. ordering supplies, stockkeeping, etc.).Laboratory hygiene including waste disposal management and safety checks.Document experimental data appropriately in an electronic laboratory notebook.Problem solving, either independently or with assistance, pertaining to experiment and/or instrumentation issues.Identify areas for improvement in laboratory operations to improve efficiency and resource usage and assist in continuous improvement activities.Understand and adhere to AbbVie corporate standards regarding code of conduct, safety, policies and procedures, and GxP compliance.Requirements:BS (0-2+ years) in scientific discipline (e.g. Chemistry, Biochemistry, or Biology) with previous laboratory experience.Experience in Microsoft Office (Excel, Power Point, and Word) required.Experience with bioanalytical techniques is preferred.Connect with peers internally and cross-functionally to facilitate communication, discuss ideas, and nurture innovation.Be open and receptive to other’s ideas and suggestions for personal improvement.Learn quickly, be adaptable and agile, and raise the bar for performance.