U.S.Pharmacopeial Convention looking for Scientist

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Post : Scientist II, CDL (Excipients) in Hyderabad

Job Description
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.

Summary of the Position
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.

This is a non-supervisory position in the Compendial Development Laboratory (CDL) within Global Laboratory Operations. The incumbent will be responsible for performing analytical method development and validations for USP/NF monographs and maintaining safety and GLP environment in the lab. This position is a component of USP’s core business and the incumbent is expected to support monograph modernization initiatives.

Roles and Responsibilities
• Search relevant literature for the USP/NF monograph modernization projects.
• Provide effective technical and scientific expertise in analytical method development and validation of excipients/ pharmaceuticals.
• Plan individually the project requirements and their completion within the time lines by coordinating with the supervisor and team.
• Responsible for preparation and review of SOPs, protocols, reports, etc.
• Preparation of development & validation reports for respective USP/NF monograph modernization projects.
• Ensure that the calibrations of the equipment are performed as per the schedule.
• Responsible for preparing, executing and completing IQ/OQ/PQ of instruments.
• Indent the required glass ware, chemicals and columns for the CDL projects.
• Maintain GLP & safety procedures while working in Lab.
• Presentation on the project pipeline and outcomes with the management will be a part of job.

Candidate Profile
Master’s Degree in Chemistry with 3-5 years of experience. Possess a fine understanding of USP/NF/FCC monographs/general chapters/general notices. Exposure to GMP/GLP/QMS environment and documentation procedures and champions the data integrity. Should be capable of performing analytical method developments and method validations using modern techniques and protocols. Good analytical skills in handling method development and Validations for Food ingredients and food products. Should have exposure to GMP/GLP environment and documentation procedures. Awareness of ISO/IEC 17025 is desirable.

Additional Information
Experience : 3-5 years
Qualification : MSc
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Tracking Code : IND 140
End Date : 20th October, 2019