Scientific Liaison–Biologics Post Vacant @ United States Pharmacopeia-India (P) Limited
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.
Name of the Post: Scientific Liaison – Biologics
Name of the company : United States Pharmacopeia-India (P) Limited
Number of Post: one
Function of the Position:
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 workingcollaboratively to improve and promote the public health.
Roles and Responsibilities:
- Monograph and General Chapter Development
- Oversees and coordinates all aspects of the development ofmonographs 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.
- Coordination/Liaison Responsibilities
- Writes general and specific subject correspondence pertaining to monographs, general chapters and various USP policyissues.
- 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 ad hoc Advisory Panels of the Council of Experts.
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.