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 - Chemicals
Job Description:
Function of the Position:
This is a professional, scientific position in which the incumbent is responsible for critical evaluation of relevant literature and laboratory reports regarding drug standards and compendial methods. The Scientific Liaison is the critical link between the Volunteer Expert Committees and USP and serves as the conduit for all scientific research, information, and testing as it relates to the documentary standards and reference materials for articles admitted to the USP Medicines Compendium (USP-MC).
Roles and Responsibilities:
• Advises, consults, and acts as a liaison with representatives of pharmaceutical
industries, regulatory bodies and scientific organizations.
• Coordinates with Analytical R&D of USP India and HQ to prepare protocols, critically evaluates and analyzes specifications and supporting data, prepares summary review report , submits and clarifies Expert committee members for the approval of the reference standards.
• Writes general and specific subject correspondence pertaining to monographs, reference standards, general chapters and various USP policy issues.
• Keeps abreast of current trends and developments in related scientific fields.
• Responds to telephone inquiries pertaining to UMC monographs.
• Assists in the formation of work assignments of ad hoc advisory panels in order to
complete various studies on revision problems.
• Communicates with other USP departments regarding projects related to validation studies,
method development and reference standards.
• Serves as representative of USP at professional meetings.
• Gives public presentations on USP matters.
• Performs other related duties as assigned.
Candidate Profile:
Minimum Requirements:
Ph.D. degree in Pharmacy, Chemistry with a minimum of three years relevant experience with USP-NF tests and standards (an equivalent combination of experience and education may be substituted). A minimum of five years experience with analytical techniques such as liquid and gas chromatography, spectroscopic, NMR, Mass Spectroscopic, Inductively Coupled Plasma, wet chemistry, etc.is required.
Knowledge, Skills, Abilities, Training and Experience:
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.
Additional Information:
Exp: 3-8 years
Location: Hyderabad
Qualification: M.Pharm, M.Sc, Ph.D-chemistry, Pharmacy
Functional Area: R&D
Industry: Pharma/Life sciences
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