Purpose:

The Analytical Stability Chemist is responsible for the coordination and organization of stability studies to ensure uninterrupted daily operations associated with procurement, dispensing, studying, analyzing and reporting of those studies while assuring compliance for Stability and Laboratory Operations. This person will interface with Marketing, Regulatory Affairs, Manufacturing, Plant QA, S&T, R&D etc to request stability samples, resolve stability related issues, and/or implement new stability studies. They may support sites globally to provide vital stability support of AbbVie’s products and associated regulatory filings worldwide. This requires execution of projects and goals in line with business operations, including planning, coordinating, directing and advising various sites, regulatory or business groups to ensure our quality stability operations align with business needs. This person also functions as the technical consultant to business operations for scientific research.

• Personnel: Assure their training is comprehensive and up to date. Identify and resolve routine stability issues without direct supervision, unless required by procedure.
• Compliance: Assure conformance to all government and corporate regulations. Provide, defend stability practices with outside organizations. Routinely meet with customers to ensure no interruptions in business due to compliance issues.
• Finance: Provides input to management for resources needed to construct budget, updates, and changes in financial plan. Ensure cost projections and estimates provided to customers and prospective customers are included in the financial plan appropriately.
• Customers: Interact with personnel from laboratories, regulatory affairs, R&D areas, and other disciplines throughout AbbVie, and with third party customers to facilitate and coordinate their stability needs. Finalize timeline and cost estimates for projects and/or service contracts to support business operations and/or external customer’s needs.
• Subject Matter Expert: Ensure research activities/projects are on track per business needs and established timeline. Direct laboratory personnel regarding testing and other activities to ensure laboratory resources and support.
• Stability: Provide timely stability services to ensure required stability studies are initiated according to filing strategies, regulatory requirements and the needs of the business operations. This includes ensuring stability protocols are written, material is obtained for studies and placed in chambers in a timely manner. Revise studies as required so as to ensure no interruption or exceptions to protocols result, which includes loading, reviewing and verifying static tables to ensure accuracy
• Data Analysis: Review, analyze and trend results to detect potential significant negative or aberrant results or trends. Communicate concerns with management, customers, product quality and laboratory personnel to ensure appropriate actions are taken and exception reports initiated. Compile clear and concise graphical and tabular data summaries.
• Stability Reporting: Author annual stability reports for assigned commercial products as requested by regulatory affairs or other affiliates. Author stability memos and historical analyses as required.
• Change Control: Author, review and approve change control documents, including change plans, change requests and associated tasks. Perform change tasks as assigned. Coordinate with plant, product quality, regulatory affairs and third party customers to ensure stability studies, documents, commitments and regulatory requirements remain consistent with product specifications.