USP is proud to be an equal opportunity/affirmative action employer. Employment selection and related decisions are made without regard to sex, gender identity, race, age, disability, religion, national origin, color, veteran status or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Post : Scientist II - Compendial Development Laboratory
• 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).
• Responsible 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.
Master’s Degree in Chemistry with 3-5 years of experience. Possess a fine understanding of USP/NF 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 developments and validations for Excipients and pharmaceuticals. Awareness of ISO/IEC 17025 is desirable.
Preferred Qualifications :
Master’s Degree in Chemistry or Pharmaceutical Sciences with 3-5 years of experience in relevant field. Exceptional breadth of excipient/pharma industry 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. Good to have hands on experience in working with chemical methods and handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, GPC/SEC-MALS, IC, ICP-OES/MS, FTIR, UV-Visible, NMR, AAS and KF. Should have fair understanding of GLP regulations and exposed to external regulatory audits. Should possess strong technical knowledge in the areas of complex molecules/compounds such as polymers, fats, oils, waxes and plants
Experience : 3-5 years
Qualification : M.Sc or M.Pharm
Location : Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : CDL
End Date : 30th May, 2022
See All Other Jobs in our Database