The U.S. Pharmacopeial Convention (USP) Scientist II, RSL in Hyderabad, India
Scientist II, RSL
The U.S. Pharmacopeial Convention (USP) is a scientific non-profit 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.
USP promotes Diversity & Inclusion at Workplace and encourages Equal Employment Opportunity and Affirmative Action
Summary of the Position
- This is a key hands-on, non-supervisory position in the Reference Standard Laboratory (RSL) responsible for performing the required analysis as a part of the project and maintaining the GLP environment in the Laboratory. The incumbent will provide technical assistance to the collaborative testing of reference standards by performing analytical tests, reviewing the data and preparing summary reports. The incumbent may execute 90-100% of their work at the bench level.
Roles and Responsibilities
Demonstrate solid scientific approach to analysis in the laboratory
Execute the analytical tests allotted by Project or Group Leader.
Verification of test protocol and giving test kit approvals, if required.
Supporting Verification, GPH, PQM, stability and other departmental teams in terms of testing and project review whenever needed.
Responsible for preparation of project evaluation reports.
Responsible for sample tracking and chemical inventory tracking in the laboratory.
Coordination with group leader to ensure completion of the projects allotted to the team.
Initial review of the project reports and documents and assisting the group leader when required.
Completing the project as per the timelines and trouble shoot the scientific aspects of the projects on need basis.
Responsible for preparation and review of SOP’s, protocols, reports etc.
Responsible for performing the calibration of the equipments as per the schedule.
Responsible for preparing, executing and completing IQ/OQ/PQ of new instruments.
Ensuring that the chemicals and column etc. are available for the projects and forward the purchase requisitions.
Taking up any additional responsibilities assigned by group leader from time to time.
Ensure all lab safety and GLP practices are maintained in the lab and participate actively in the internal and external audits and certification.
- PhD. in Chemistry with 1-2 years or Master degree in Chemistry with 3-5 years of relevant laboratory experience.
- Proven track record of consistently delivering projects on time and with high quality. Proficient with pharmaceutical testing requirements and test protocols involving compendial methods for reference materials (USP, FCC, NF, etc.). Expert in Chromatographic analysis, especially in HPLC and troubleshooting, proficient in other related analytical instrumentation (Titrations, IR, KF, UV, Thermal, Elemental analysis etc.), Takes personal responsibility for delivery of projects to customers. Ability to embrace and lead change. Extremely adaptable. Excellent communication skills, both written and verbal. Having knowledge of Empower software, ELN, ERP, QR coding system are added advantages. Prior experience in a high volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.
Job Category Scientific