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Shipeng Yu
Senior Research Scientist at Endo Pharmaceuticals
Professional Background
Shipeng Yu is a highly accomplished Senior Research Scientist with extensive expertise in pharmaceutical product development, particularly in the realms of New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA). With a hands-on approach, Shipeng has dedicated his career to the intricate field of formulation development, showcasing a remarkable ability to design and develop solid oral dosage forms. His comprehensive knowledge spans across preformulation, formulation, and scalable process development, making significant contributions in leading formulation projects while collaborating with interdisciplinary teams across various domains, including analytics, clinical, and project management.
Throughout his career, Shipeng Yu has accumulated a wealth of experience that is integral to the successful development of pharmaceutical products. His adeptness in managing project timelines and leading project activities ensures streamlined progress and fosters a collaborative environment in achieving project goals. He has not only excelled in formulation development but also engaged in writing Chemistry, Manufacturing, and Controls (CMC) documents that are essential for regulatory submissions. This level of engagement underlines his crucial role in the intricate lifecycle of pharmaceutical product development.
Education and Achievements
Shipeng Yu's educational background is a testament to his commitment to advancing his knowledge and expertise in the field of pharmaceutical sciences. He studied for his Master's Degree in Medicine at the esteemed Peking University, a prestigious institution known for its rigorous academic programs in the health and medical sciences. Shipeng furthered his education by pursuing a Ph.D. in Pharmaceutical Science within an interdisciplinary program at the University of Tennessee Health Science Center, where he deepened his understanding of pharmaceutical mechanisms and drug formulation principles.
Achievements
Among his notable achievements, Shipeng has leveraged his strong analytical and problem-solving skills to significantly influence product development and enhance the drug design process. His hands-on experience with solid dosage form processes and manufacturing equipment places him at the forefront of pharmaceutical innovation. Furthermore, he possesses a fundamental working knowledge of Quality by Design (QbD) principles and current Good Manufacturing Practices (cGMP), both vital components in developing sophisticated and regulatory compliant pharmaceutical products.
Shipeng's renowned ability in pharmacokinetic modeling has allowed him to integrate theoretical concepts into practical applications, ultimately pivotal in product development. His specialized skills in formulation development, process development, and scale-up experience markedly distinguish him as an asset in the pharmaceutical industry.
With his depth of knowledge and experience, Shipeng Yu stands as a leader in the field of pharmaceutical product development, continuously contributing to advancements and innovations in solid oral dosage forms, while prioritizing the integrity and efficacy of new medicinal products.