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Kaisheng Huang

Sr. Director, Biologics CMC at Dermira, Inc.

Professional Background

Kaisheng Huang is a distinguished professional in the biotech industry, specifically renowned for his extensive expertise in drug development. With a deep background in analytical development, quality control, formulation development, process development, and regulatory filing, he has played a critical role in advancing pharmaceutical innovations. His career trajectory has equipped him with a rich understanding of the complexities involved in drug development, particularly under the stringent guidelines of current Good Manufacturing Practice (cGMP) and International Council for Harmonisation (ICH) and Food and Drug Administration (FDA) regulations.

Currently, Kaisheng is the Sr. Director of Biologics CMC at Dermira, Inc., where he leads the development and oversight of drug products from concept through to clinical trials and beyond. His expertise spans various stages of drug development, including Investigational New Drug (IND) applications, Investigational Medicinal Product Dossiers (IMPD), and the management of Phase 1 through 3 clinical trials. His ability to navigate the intricacies of compliant regulatory submissions not only highlights his skill set but also showcases his commitment to advancing drug therapy for patients in need.

Prior to his role at Dermira, Kaisheng served as Sr. Director, CMC, Protein Manufacturing at Anthera Pharmaceuticals. He transitioned to this position after a successful tenure as Director, where he honed his skills in managing the lifecycle of drug products. His earlier roles included significant positions at Achaogen and Geron, where he was instrumental in leading the analytical development and quality control teams, contributing to pivotal projects that enhanced the understanding of biologics and small molecule therapeutics. At Geron, he took on complex leadership responsibilities, overseeing both process development and manufacturing operations, which enabled the company to advance its research initiatives efficiently.

Kaisheng's career also includes contributions at Amgen, where he worked as a Scientist in Analytical/Assay Development. His role there solidified his foundation in assay validation and development, establishing best practices that would guide his subsequent ventures in the pharmaceutical landscape. Moreover, his academic background includes serving as a Research Assistant Professor in the Department of Biochemistry at the University of Wisconsin-Madison, coupled with a postdoctoral fellowship at Washington State University, highlighting his strong academic credentials alongside his industry experience.

Education and Achievements

Kaisheng Huang has pursued an impressive academic journey, earning a Doctor of Philosophy (Ph.D.) in Medicinal Chemistry from Peking Union Medical College. His rigorous education has furnished him with a profound theoretical knowledge base and practical skills vital for his future endeavors in drug development. Prior to obtaining his Ph.D., he completed a Master of Science (M.S.) in Medicinal Chemistry at China Pharmaceutical University. This solid foundation in medicinal chemistry underpins his adeptness at navigating complex scientific challenges within the pharmaceutical sector.

In addition to his impressive educational background, Kaisheng exhibits mastery in analytical method lifecycles. He adeptly manages initiatives involving method development, qualification, validation, and transfers to Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs). His role involves overseeing stability and release testing, as well as investigating Out-of-Specification (OOS) and Out-of-Trend (OOT) occurrences, ensuring rigor and compliance throughout the drug lifecycle. His contributions to method management and quality assurance play an essential role in ensuring that drug products meet exacting standards necessary for clinical processes.

Notable Achievements

Some of Kaisheng Huang's most notable achievements include:

  • Leading diverse teams in the successful navigation of the drug development process from initial research and development through to clinical trials, effectively meeting regulatory milestones.
  • Advancing analytical methods that significantly improve drug quality and efficacy, showcasing his commitment to excellence in drug development practices.
  • Establishing robust quality control measures that ensure compliance with global regulatory standards, thus enhancing drug product reliability.
  • Contributing to numerous high-stakes projects, resulting in successful regulatory submissions that facilitate patient access to innovative therapies.

His continued pursuit of excellence in the biotech realm demonstrates his unwavering commitment to driving advancements in healthcare and improving patient outcomes. Kaisheng Huang exemplifies the unique blend of scientific expertise, strategic leadership, and unwavering dedication that is essential for success in the ever-evolving landscape of pharmaceutical development.

Related Questions

How did Kaisheng Huang's educational background in Medicinal Chemistry influence his career in drug development?
What are the key challenges Kaisheng Huang faced during his time at leading biotech companies, and how did he overcome them?
In what ways has Kaisheng Huang contributed to innovations in biologics and small molecule therapeutics?
How does Kaisheng Huang ensure compliance with cGMP and regulatory standards in his role at Dermira, Inc.?
What notable projects has Kaisheng Huang led that demonstrate his expertise in analytical development and quality control?
Kaisheng Huang
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Location

San Mateo, California, United States