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With limited guidance from supervisor, the employee plans and independently executes analytical chemistry analyses, including but not limited to, HPLC, UPLC, GC, particle size distribution, physical appearance, and viscosity of drug substances and products as well as any method evaluation activities assigned by the supervisor. With limited guidance, drafts standard stability protocols/ reports and special study protocols/reports and maintain the integrity of the stability program. Under limited supervision, compiles, evaluates and statistically analyzes technical data and generates stability data tables and plots in support of specification development and regulatory submissions. Under supervision, perform method development, evaluation, and validation activities. Identifies any atypical data and report to supervisor with probable causes and suggests resolution. Demonstrates a basic understanding of regulatory requirements associated with stability studies. Troubleshoots instrumentation problems and propose solutions with minimum guidance from supervisor. Additionally, the employee must be proactive in critically interpreting data and learning new techniques. The employee must have proactive, cross functional communication skills and is expected to maintain a current knowledge and understanding of global regulatory stability requirements and expectations as well as cGMP practices.
The employee must conduct their work activities in compliance with all Allergan internal requirements and with applicable regulatory requirements. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources and general business policies, requirements and objectives.
Education and Experience
Strong technical writing and communication skills. Must be proficient using Word, Excel and statistical programs for analytical data evaluation. Ability to review and understand new and innovative analytical methods. In addition, the following career elements are required:
• M.S. in Analytical Chemistry or related discipline with 0-2 years of experience or B.S. in Analytical Chemistry or related discipline with 2-5 years of experience in analysis of pharmaceutical products or pharmaceutical method development and validation.
• Minimum 2 years of experience in the analysis of data and writing of technical protocols, reports, and submission ready documents.
Essential Skills and Abilities
Knowledge of chromatographic theory and technology is required. Ability to troubleshoot experimental problems and propose solutions. Working knowledge of HPLC and GC. Working knowledge/experience with chromatographic data acquisition systems. Excellent experimental skills, demonstrated ability to design and plan experiments, interpret data and present conclusions. Ability to troubleshoot experimental problems and propose solutions. Knowledge and use of basic statistics (hypothesis testing and regression analysis). Working knowledge of cGMPs and basic understanding of regulatory requirements. Ability to operate with a minimum of supervision in daily activities and to exercise good judgment is required.
Excellent written and oral communications are required as well as proven time management and analytical chemistry skills. In addition the position, a working knowledge of cGMPs, FDA requirements, and a basic understanding of global regulatory requirements associated with stability studies is desired.
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