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Scientist II, CDL

Scientific

Hyderabad, AP

ID:IND 239

Full-Time/Regular

**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 in the Compendial Development Laboratory (CDL) within Global Laboratory Operations. The incumbent will be responsible for performing USP-NF/FCC method development and method validation projects 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**

+ Literature search for the assigned projects.

+ To ensure the projects requirements by coordinating with the Group Leader and other stakeholders.

+ To involve in project execution, method development and validation of assigned projects.

+ To execute method development and validation with minimum supervision.

+ To prepare method development and validation reports with minimum supervision.

+ Coordination with cross-functional to arrange project requirements.

+ To acquire the knowledge on different drug products handling and samples preparations.

+ Provide effective technical and scientific expertise regarding drug substance and drug product analytical development.

+ Engage in project planning, execution, method development and validation of projects according to set standards such as USP general chapters, guidelines, SOPs and protocols.

+ Ensure the project updates are provided to the supervisor on regularly.

+ To coordinate with Group Leader to complete assigned projects within timelines.

+ Responsible for preparation and review of SOPs, protocols, reports etc.

+ Responsible for review of the records and documents.

+ To ensure that the calibrations of the equipment are performed as per the schedule.

+ Responsible for preparing, executing and completing IQ/OQ/PQ of new instruments.

+ To indent the required glass ware, chemicals and columns for the assigned projects.

+ To maintain GLP & safety procedures while working in Lab.

**Required Skills**

**Basic Qualifications**

+ 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.

**Required Experience**

**Preferred Qualifications**

+ Master’s Degree in Chemistry (Analytical / Organic) or Pharmaceutical Sciences with 3-5 years of experience. Excellent technical writing and oral communication skills required. Must be able to communicate effectively with diplomacy and enthusiasm. Technical and analytical skills required including the ability to interpret technical information. Must have hands on experience in working with chemical methods and handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, IC, ICP-OES/MS, FTIR, UV-Visible. Should have fair understanding of GLP regulations and exposed to external regulatory audits

**Job Category** Scientific

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About USP

United States Pharmacopeia Type Nonprofit Founded 1820 Headquarters Rockville, Maryland, USA Key people Ronald T. Piervincenzi, Chief Executive Officer[1] Website http://www.usp.org The United States Pharmacopeia (USP) is a pharmacopeia (compendium of drug information) for the United States published annually by the United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that owns the trademark and copyright. The USP is published in a combined volume with the National Formulary (a formulary) as the USP-NF.[2] If a drug ingredient or drug product has an applicable USP quality standard (in the form of a USP-NF monograph), it must conform in order to use the designation “USP” or “NF”. Drugs subject to USP standards include both human drugs (prescription, over-the-counter, or otherwise) and animal drugs. USP-NF standards also have a role in U.S. federal law; a drug or drug ingredient with a name recognized in USP-NF is considered adulterated if it does not satisfy compendial standards for strength, quality or purity. USP also sets standards for dietary supplements and food ingredients (as part of the Food Chemicals Codex). USP has no role in enforcing its standards; enforcement is the responsibility of Food and Drug Administration (FDA) and other government authorities in the U.S. and elsewhere.