The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Post: Science & Standards Liaison
Function of the Position
This is a hands-on, non-supervisory role involving the standard setting activity and performing a variety of routine day-to-day duties with regard to developing reference standards and documentary standards. The position serves as the liaison between the pharmaceutical/biotechnology industry, regulatory agencies, USP departments and USP Expert Committees. In this role, the incumbent will provide expertise, leadership, and guidance to USP Expert Committees by facilitating the exchange of highly technical information and working collaboratively to improve and promote the public health.
Roles and Responsibilities
• Oversees and facilitates the development of assigned USP biologics reference materials
• Establishes reference standard configuration based on the uses of the standard in the monograph or chapter.
• Designs and oversees the execution of collaborative testing, once a candidate material has been sourced. Analyzes results and prepares data
• Communicates with other USP departments regarding projects related to collaborative studies, early procedure evaluation studies, validation studies, methods development, reference standards, and other cross-cutting activities.
• Oversees and coordinates all aspects of the development of monographs and General Chapters to the USP-NF, from receipt of the initial submission to the publication of the documentary standard.
• Technically evaluates and analyzes specifications and supporting data, and translates specifications and test methods into USP editorial style and format.
• Writes general and specific subject correspondence pertaining to monographs, general chapters and reference standards.
• Keeps abreast of current trends and developments in related scientific fields, particularly in the area of recombinant therapeutic proteins, such as monoclonal antibodies and cytokines and their analysis.
• Responds to inquiries pertaining to USP-NF monographs and General Chapters (as assigned).
• Serves as representative of USP at professional meetings.
• Gives public presentations on USP matters (as assigned).
• Prepares revision proposals and provides assistance, as needed, for the USP Expert Committees and ad hoc Advisory Panels of the Council of Experts.
Education and Experience:
Master’s or Ph.D in Life Sciences. Molecular Biology, Biochemistry with a minimum of 4 years of relevant experience with knowledge of method developmental aspects and concepts of validation and data evaluation. Experience of working with recombinant therapeutic proteins is mandatory to understand the technical complexities for evaluating monograph specifications.
An equivalent combination of experience and education may be substituted. Must have experience with analytical techniques such as bioassays, liquid chromatography, electrophoresis, capillary electrophoresis and other biochemical methods commonly used in the biopharmaceutical industry.
Knowledge, Skills, Abilities:
Excellent presentation and communication skills (written and oral) is a must. Knowledge of internet and electronic database searches required. Practical experience in scientific, analytical techniques. Project Management skills required Able to establish and nurture relationships with individuals of varying backgrounds and learning styles. Able to operate independently where appropriate, yet understands when to escalate issues and how to establish effective working relationships. Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills. Knowledge of the pharmaceutical industry and the associated regulatory framework is essential. Ability to prioritize tasks and manage multiple projects simultaneously. Must be able to share technical information with non-technical or non-scientific staff, and to communicate effectively with representatives from pharmaceutical companies, government, and academic institutions. Ability to persuade corporations to collaborate with USP on various projects. Experience with, and knowledge of the USP-NF is preferred.