Develop and validate analytical methods for potency, dosage uniformity, and stability testing of transdermal products.
Support R&D testing of developmental transdermal products. Perform testing of transdermal products for residual solvents as well as other duties and special projects as required.
- Develop and validate analytical methods. Write standard test procedures, method validation protocols and method transfer protocols.
- Coordinate transfers of methods to the Quality Control Department.
- Coordinate HPLC testing; make detailed observations, analyze data, and interpret results.
- Calibrate analytical instrumentation at scheduled intervals.
- Exercise technical discretion in the design, execution and interpretation of experiments that contribute to current strategies.
- Investigate possible degradation pathways of drugs in transdermal systems and provide information leading to degradant identification, product design and stability improvement.
- Prepare technical reports, summaries, protocols, and quantitative analyses.
- Maintain familiarity with current scientific literature and trends.
- Investigate new methods and technologies for project advancement.
- Oversee the activities of and provide guidance to Assistant/Associate Analytical Chemist.
- Implement Good Manufacturing Practices in the laboratory.
- Perform other duties and special projects as required.
Judgment / Decision Making:
Work performed under general direction with periodic review of assignments. Some improvisation in the application of procedures and methods required.
Education & Experience:
Bachelor’s degree in Chemistry or related field with 5 to 7 years of experience, Master’s degree with 1 to 3 years of experience, or PhD 0 to 3 years of experience. Knowledge of scientific principles, procedures, methods and techniques. Laboratory background with an understanding of chromatographic analysis training and separation theories. Appropriate work experience with proven ability for practical application of theoretical knowledge. Good verbal and written communication skills; PC literate.
Laboratory environment with exposure to chemicals, fumes, and caustics. Duties performed could result in minor injury.
Visual and manual dexterity required to perform experiments and analyze data. Lift and carry objects weighing up to 40 pounds.
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