Job Description

About AbbVie

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. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

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.

Qualifications

• Education and Experience: BS with 6 years or MS with 3 years or PhD with 3 years’ experience in a government regulated pharmaceutical industry.
• Related knowledge of Product Quality, Quality Control Lab Operations is required.
• Ability to work independently to meet operational goals and business needs.
• Ability to make operational decisions consistent with procedures with minimum direction from immediate manager.
• Ability to interact and establish interaction with internal/external customers.
• Shows broad understanding of the issues relevant to technical/science and business

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. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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