Huiping Tu

About Huiping Tu

Director of Biologics and Biotechnology Laboratory in U.S. Pharmacopeia Convention (USP). Responsibilities include managing the Microbiology, Bioanalytical and Bioassay teams, overseeing daily operation of the laboratory and interactions with cross functional departments to promote good quality therapeutic products globally. A seasoned and versatile scientist with deep and broad expertise in microbiology, molecular/cell biology, biochemistry, and analytical chemistry. More than 20 years’ experience in pharmaceutical industry, academia, and regulatory science with demonstrated leadership and technical expertise in a fast paced and science-focused matrixed environment. Successfully led and managed scientific collaborations involving innovators and biosimilar manufacturers to develop public standards supporting pharmaceutical biologics development and innovation and to expand USP Biologics portfolio to cover therapeutic recombinant proteins, monoclonal antibodies and cell and gene therapy products. In-depth knowledge of USP-NF tests with up to date understanding of FDA regulations and ICH guidelines. A self-motivated and dedicated collaborator with strong interpersonal communication skills. Effective in time-management and strong organization skills with excellent written, oral, and presentation skills. Proven track record of building efficient, high performing teams and managing both on-site and remote operations. Strong ability to build effective, productive relationships with external and internal stakeholders and scientific collaborators.

Experience

1. Senior Principal Scientist

   US Pharmacopeia

   Oct 2022 — Present · US

   work with Microbiology Expert Committee and Statistics Expert Committee to lead the development of USP microbiology and Bioassay related General Chapters.

Education

• East China Normal University

  Ph. D, Physiology

  1997 — 2000

• East China Normal University

  M.S., Organic Chemistry

  1990 — 1993