The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities 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 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Post : Scientist IV / III, Reference Standards Evaluation
Job Description
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.
Roles and Responsibilities
• 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 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
Scientist IV
MSc/MPharm with 8-10 yrs of experience (or) Ph.D. with 3-5 yrs of experience
Scientist III :
MSc/MPharm with 6-8 yrs of experience (or) Ph.D. with 1-3 yrs of experience
• Ability to read and interpret spectroscopic analyses data (NMR, IR, MS etc.)
• Hands on experience on chromatographic techniques (HPLC, GC)
• Ability to handle multiple priorities in a fast-paced environment.
• Excellent written and verbal communications skills.
Additional Desired preferences
• Hands on experience spectroscopic analyses data (NMR, IR, MS etc.) and knowledge on chromatographic techniques.
• XRD, Polymorphic studies exposure
• Stability studies exposure
Additional Information
Experience : 5+ years
Qualification : MSc/MPharm
Location : Hyderabad, IND
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Reference Standards Evaluation
End Date : 20th February 2025
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