The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Post : Scientist III, Reference Standards Evaluation
Brief Job Overview
This is a hands-on non-supervisory position responsible for the oversight and successful implementation and completion of all activities pertaining to a portfolio of Reference Standards (RS)/Material Strategy program (CRM/ARM etc.). This incumbent is responsible for the timely preparation of procurement specification and collaborative testing protocols for all RS lots, technical assistance for collaborating labs, analytical data review and preparation of summary reports, preparation of packaging and Quality Control testing instructions.
Job Description
The position's purpose should provide a high-level overview of why the position exists and briefly identify the most critical priorities of the position. This is an opportunity to highlight any features or duties of the role related explicitly to the Department's Diversity, Equity, Inclusion & Belonging work.
• Responsible for timely preparation of collaborative testing protocols for new/replacement RS lots, technical assistance for collaborating labs
• To review the analytical data received from the Collaborators and to prepare summary reports and RSCEP packages, preparation of packaging and QC testing instructions and assigning periodic re-test intervals. Independently maintains successful scheduling operations, necessary documents, complete and accurate information; and addresses quality issues to ensure availability of reference standards in a complex portfolio.
• To Draft product planning documents (PPD), coordinates with labs, and reviews/interprets data from international collaborative studies.
• To Coordinates for any additional necessary testing and assists other staff members in addressing the comments.
• To provide correct guidance on the interpretation of test data, Proposes and designs studies to obtain necessary data to resolve complaints.
• To support Documentary Standard team by peer review of draft monograph
• To support Material Strategy program (CRM, ARM)
• To demonstrate technical understanding to internal and external audiences regarding USP's Reference Standards program.
• Engages in conversation about reference standards issues. Addresses general customer technical inquiries and thoroughly investigates customer complaints with minimal guidance.
• Presents information to USP staff and external audiences.
• Facilitates additional cross-functional activities with other departmental staff and other USP staff.
• Performs other related duties as assigned.
Candidate Profile
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience :
• MSc/MPharm with 6-8 yrs of experience
• Ph D with 1-3 yrs of experience
Additional Desired Preferences
• Ability to read and interpret spectroscopic analyses data (NMR, IR, MS, Raman, XRD etc.)
• Hand on experience on chromatographic techniques (HPLC, GC, SFC)
• Ability to handle multiple priorities in a fast-paced environment.
• Excellent written and verbal communications skills.
Additional Information
Experience : 6-8 years ; Ph.D with 1-3 yrs
Qualification : Ph.D, M.Pharm, MSc
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Reference Standards Evaluation
End Date : 30th June 2024
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