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The JD is shown below:
1. Design technically sound stability studies for liquid parenteral pharmaceutical products that meet ChP, EP, sFDA, and ICH criteria for establishment of product expiry. Write protocols, conduct studies, and write reports.
2. Independently generate innovative solutions to complex problems through the use of multiple disciplines and technical principles.
3. Understand and apply statistical methods as needed to justify/establish appropriate product expiry.
4. Understand application of accelerated stability studies to establishment of expiry including projection of stability under different storage temperatures/conditions.
5. Understand and apply interpretation of analytical methods and determination of stability indicating analytical methods, including HPLC chromatographic separation, UV/visible absorption, particulate matter, pH, to ensure appropriate testing is conducted to fully characterize stability profile of products. Participates in lab investigations as author of technical evaluations that characterize the stability trending of suspect data.
6. Sought out by other teams and individuals to offer technical advice; Serve as technical consultant to research and manufacturing personnel in providing stability assessments and requirements for product enhancements/changes.
7. Develop products/processes (design, quality improvements, research techniques, etc.) incorporating multiple tasks within area of expertise.
8. Incorporate knowledge of customer use and product design to predict product effectiveness/anticipate potential failures. Analyze executed designs and results and modify them as needed to increase product/processes acceptance, quality and reliability.
9. Develop new or improved techniques and procedures around specific tasks; write and implement SOP's. Develop research outlines for large scientific projects. Apply state-of-the-art techniques in the area of expertise to develop new or improved products.
10. Apply specialized technical and theoretical knowledge in creative ways to a broad range of difficult problems. Contribute to technical feasibility analysis, which incorporates multiple disciplines where new and unproven methods and technologies are required. Generate innovative solutions to highly complex problems where little clear precedence exists. Incorporate advanced theories, methods and technologies from around the world to develop new innovative products/processes.
11. In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
12. Present research results at external conferences, publish articles in journals and/or file patents.
13. Must be able to supervise and/or direct the laboratory work for lower level research associates.
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