Job opportunity for Senior Scientist at U.S. Pharmacopeial Convention (USP)

The U.S. Pharmacopeial Convention (USP) is a self-reliant scientific institution that partners with leading global health and scientific experts to create high standards for medications, dietary supplements, and food constituents. USP’s central principle, which states that Fairness leads to Excellence, is reflected in our core principle of Dedication to Excellence. This principle is upheld by our dedicated team of over 1,100 skilled individuals spread across five international sites. Their collective effort is focused on fulfilling our mission to enhance the availability of secure and quality medicines and supplements on a global scale.

Post: Senior Scientist I, Reference Standards Laboratory

Brief Job Overview: Non-Supervisory Role | GLP Environment Management | Collaborative Testing

Job Description:

• Execution of assigned analytical tests under Project Leader or Group Leader guidance.
• Review and approval of test protocols and kits as assigned by the team or group leader, if necessary.
• Support for Verification, GPH, PQM, stability, and other departmental teams in testing and project review.
• Mentor and train junior team members in day-to-day activities.
• Manage sample archival, tracking, and chemical inventory in the laboratory.
• Coordinate with the group leader to ensure timely project completion.
• Initial review of project reports and documents, assisting the group leader when needed.
• Ensure project completion within timelines and troubleshoot scientific aspects as required.
• Prepare and review SOPs, protocols, reports, etc.
• Perform equipment calibration as scheduled.
• Execute IQ/OQ/PQ of new instruments.
• Ensure availability of chemicals and equipment for projects, and submit purchase requisitions.
• Undertake additional responsibilities assigned by the group leader.
• Uphold lab safety, GLP practices, and active participation in audits and certification.
• Maintain and follow QMS, handle incidents, and deviations.

Candidate Profile:

Demonstrated Mission Understanding | Credibility Building | Inclusive Excellence

• Ph.D. in Chemistry or Master’s degree in Chemistry/Pharmacy.
• 7-10 years of relevant lab experience for Ph.D. candidates.
• 11-13 years of relevant lab experience for master’s degree candidates.
• Proven track record of on-time, high-quality project delivery for formulations and APIs.
• Expertise in chromatographic analysis, especially HPLC, GC, IC, LC-MS, and GC-MS.
• Proficiency in other related analytical instruments: Mass Spectrometry, Titration, IR, KF, UV, Thermal Analysis, Elemental Analysis, etc.
• Effective written and verbal communication skills.
• Knowledge of Empower software.
• Strong technical and analytical skills for independent issue resolution.
• Familiarity with GLP regulations and external regulatory audits.

Additional Desired Preferences:

Advantageous Knowledge | Enhanced Instrument Experience | Compendial Methods

• Familiarity with Lab Management System, Electronic Laboratory Notebook, ERP, QR coding system.
• Hands-on experience with ICP-OES/MS instruments.
• Understanding of monograph procedures and participation in compendial methods (USP, FCC, NF, etc.).
• Previous exposure to high-volume pharmaceutical manufacturing QC lab, Analytical R&D, or contract pharmaceutical analytical lab testing organization.
• Awareness of ISO/IEC 17025 is desirable.

Additional Information:

• Experience: 7-10 years
• Qualification: Ph.D. or M.Pharm, MSc
• Location: Hyderabad
• Industry Type: Pharma / Healthcare / Clinical Research
• End Date: 20th September 2023
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