南京招聘

Summary:

• Focus on process improvement, and or operational excellence initiatives for R&D stability studies that can be transferred to the plant.
• As a technical expert in conducting product stability studies, apply an in-depth understanding of multiple disciplines and businesses to find innovative solutions to solve technical challenges or move projects forward.
• Create and execute complex design and technical tasks, integrating information from a variety of disciplines.
• Recognized for technical expertise in liquid parenteral pharmaceutical solutions (including experience with products packaged in semi-permeable container systems) with emphasis on design, implementation and assessment of stability studies.
• As a recognized technical expert, must function as technical matter expert to consult with the plants on operational stability issues such as setting expiry and problem solving on stability issues.

Essential Duties and Responsibilities:

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.

Qualifications:

· Must possess strong knowledge of scientific disciplines, including statistical analysis, analytical chemistry, organic chemistry, and solid knowledge of related disciplines, plus knowledge of quality and general business systems.

· Must possess strong ability to negotiate for resources and influence others internally and externally.

· Must be able to challenge the status quo.

· Can comfortably handle risk and uncertainty; can decide and act without having the total picture.

· Fluent in Chinese and English language with reasonable speaking and writing skills

· MS with at least 6-8 years, or PhD with at least 2-4 years of relevant experience. GMP/GLP research experience is essential.

· Lab experience including leadership of technical teams, and project management experience is desirable.

· Experience designing registration stability studies and evaluating stability data is essential.