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: Scientific Liaison (Biologics)
This is a hands-on, non-supervisory role that 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:
Monograph and General Chapter Development
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 various USP policy issues.
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).
Prepares revision proposals and provides assistance, as needed, for the USP Expert Committees and ad hoc Advisory Panels of the Council of Experts.
Candidate Profile :
Ph.D. degree in Molecular Biology or Microbiology or Life Sciences with a minimum of 5 years years relevant experience with The knowledge of method developmental aspects and concepts of validation and data evaluation should be there. Experience with working on recombinant therapeutic proteins is mandatory to understand the technical complexities for evaluating monographs, specifications etc.
An equivalent combination of experience and education may be substituted. Must have experience with analytical techniques such as flow cytometry, bioassays, NAT, viral titer assays, and In this case, liquid chromatography, electrophoresis, capillary electrophoresis etc should also be included as they are also important techniques.
Knowledge, Skills, Abilities:
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. Strong presentation and communication skills (written and oral). Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills. Knowledge of internet and electronic database searches helpful. 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.
Experience: 5-10 years
Education: B.Sc - Bio-Chemistry, Chemistry ; M.Pharm
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
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