The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years.
Post: (Associate) Scientific Liaison, Biologics and Biotechnology
Job Description:
Function of the Position:
This position is a 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 and Expert Panels by facilitating the exchange of highly technical information and working collaboratively to improve and promote the public health. The candidate will collaborate with government, industry, and academia; leverage considerable scientific expertise to a new area within USP and provide guidance and support in the area of biologics and biotechnology.
Monograph and General Chapter Development:
Oversees and coordinates all aspects of the development of monographs and General Chapters to the USP-Evaluates and analyzes specifications and supporting validation data, and translates specifications and test methods into USP editorial style and format.
Oversees and coordinates all aspects of the development of monographs and General Chapters to the USP-NF
Evaluates and analyzes specifications and supporting validation data, and translates specifications and test methods into USP editorial style and format.
Coordination/Liaison Responsibilities:
Writes general and specific subject correspondence pertaining to monographs, general chapters and various USP policy issues. Plans and oversees necessary laboratory work for method development and verification as needed.
Communicates with other USP departments regarding projects related to validation studies, methods development, reference standards, and other cross-cutting activities.
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).
Volunteer Committees:
Prepares revision proposals and provides assistance, as needed, for the USP Expert Committees and Expert Panels of the Council of Experts.
Minimum Requirements:
Ph.D. degree in Biochemistry, Virology, Biology, or Pharmacy, with a minimum of five years relevant experience in analytical development for protein therapeutics. Or a Master's degree and seven years of related experience. An equivalent combination of experience and education may be substituted. A minimum of five years experience with relevant virology and immunology techniques is desirable.
Knowledge, Skills, Abilitiess and Training and Experience:
Able to establish and nurture relationships with individuals of varying backgrounds . Able to operate independently and establish effective working relationships. Strong presentation, communication , and organizational skills. Practical experience in scientific, analytical techniques. Project Management skills required. 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.
Additional Information:
Exp: 7 years
Location: Rockville, MD - USA
Qualification: Ph.D, M.Pharm, M.Sc
Functional Area: R&D
Industry: Pharma/Life sciences
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