Scientist

The primary purpose of the position is to provide technical support and product expertise for day-to-day production, process investigations, and continuous improvement for drug product manufacturing at the AP16 manufacturing facility. This support includes AbbVie products as well as products manufactured for external customers. Provide technical assistance for the implementation of changes in manufacturing equipment, batch size, and ingredient supplier. Ensure that products and processes are kept in compliance with current industry regulations and AbbVie quality standards, including validation and filing requirements. Provide quick resolution of production issues to maintain product quality and delivery. Actively contribute to risk assessments for validation, process changes, and implementation of new systems and equipment. Good communication and writing skills are critical to success in this position.

Responsibilities:

• Provide technical support for assigned products and manufacturing operations. This includes support for process improvements as well as investigations. Activities include problem solving, evaluating deviations, assessing impact on drug product performance, manufacturing documentation changes, etc.
• Serve as change owner for projects impacting drug product manufacturing processes.
• Provide consistency across the plant through sharing of problem-solving activities and maintaining updated technical product history.
• Serve as technical liaison between plant and other divisions (within and outside of AbbVie) as needed for transfer of products, evaluation of test data, progress of new projects, etc.
• As needed, provide technical expertise and coordinate activities to develop scaled-up or scaled down processes for commercial products for development activities.
• Evaluate new process equipment and advise management about areas of opportunity in the application of novel technologies, process optimization activities, or proposals for improvement of product quality.
• As needed develop experimental plans, collate data, organize results, and apply statistical methodology to those results. Present numerical information through computer readouts, graphs, charts and tables, written reports and/or other methods.

Level of position is commensurate upon education and experience of the candidate .

Basic:

• Bachelor's Degree, or equivalent preferred, preferably in Pharmacy, Chemical Engineering or Natural Sciences.
• The incumbent should be proficient in project management and be able to work within a multidisciplinary group in order to bring assigned projects to completion/closure.
• Experience with multiple manufacturing processes such as high shear granulation, compressing, and coating is required.
• Computer literate with knowledge of statistical methods, data manipulation and interpretation. Candidate must possess good administrative, communication, and interpersonal skills.
• Effectiveness in managing multiple assignments and ability to adapt to changing priorities, and switch tasks based on those priorities, while maintaining excellent customer service levels is required. Candidate must have a good track record of working across functions to obtain decision approvals for critical courses of action, whether due to planned or exception events.
• Experience with Soltraqs, Minitab, Discoverant, OSI Pi, SAP, and POMs is desired

Equal Opportunity Employer Minorities/Women/Veterans/Disabled