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Post : Scientist I - Compendial Development Laboratory
Job Description
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.
• Responsible for the complete lifecycle of the monograph modernization / development project (initiation, execution, reporting, & completion).
• esponsible for method development and validations (DS/DP/Excipients), using chromatography (HPLC, GC) techniques.
• Should have worked on chromatography (HPLC, GC) techniques.
• Should have experience of method development and validations (DS/DP/Excipients).
• Responsible for design, review, and execution of method development experiments and perform method validation in accordance with laid down procedure.
• Responsible for preparation of method validation protocols and reports.
• Engage in project planning, execution, method development and validation according to set standards as USP general chapters, guidelines, SOPs and protocols.
• Plan individually the project requirements and their completion within the timelines by coordinating with the supervisor and team.
• Responsible for regular maintenance of assigned instruments.
• Ensure that the calibrations of the equipment are performed as per the schedule.
• Responsible for review of IQ/OQ/PQ documents of instruments.
• Indent the required glass ware, chemicals, and columns for the CDL projects.
• Maintain GLP & safety procedures while working in Lab.
Candidate Profile
Master’s Degree in Chemistry with 1-3 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 Drug substance, Drug products, Food ingredients and food products. Should have exposure to GMP/GLP environment and documentation procedures. Awareness of ISO/IEC 17025 is desirable.
Preferred Qualifications: Master’s Degree in Chemistry (Analytical / Organic) or Pharmaceutical Sciences with 1-3 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, FTIR, UV-Visible. Should have fair understanding of GLP regulations and exposed to external regulatory audits.
Additional Information
Experience : 1-3 years
Qualification : M.Sc or M.Pharm
Location : Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : CDL
End Date : 30th May, 2022
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