The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit 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.
Post: Senior Scientist I, Reference Standards Evaluation
Job Description
Function of the Position:
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). This incumbent is responsible for the timely preparation of procurement specification and collaborative testing protocols for new RS lots, technical assistance for collaborating labs, analytical data review and preparation of summary reports, preparation of packaging and Quality Control testing instructions, and assignment of periodic re-test intervals
Job Duties
- This is a Non supervisory position in Reference standard Evaluation department, responsible for oversight and successful implementation and completion of all activities pertaining to a portfolio of Reference Standards (RS).
- Responsible for timely preparation of procurement specifications and collaborative testing protocols for new 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.
- Drafts planning documents, coordinates with labs, and reviews/interprets data from multi-laboratory studies
- To submit collaborative study summary reports to RSE HQ and subsequent approval for each RS lot. Addresses the concerns of Reference Standard Committee (RSC) members to achieve successful approval of RSCEPs.
- To Coordinates for any additional necessary testing and assists other staff members in addressing the comments.
- 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.
- To facilitate additional cross-functional activities with other departmental staff and other USP staff.
- To perform other related duties as assigned.
Candidate Profile
Minimum Requirements:
Ph.D. Or MSc degree in Chemistry or Pharmacy, with 5-7 years of relevant experience in pharmaceutical analysis, including laboratory experience in compendial methods and administrative experience related to USP programs
Knowledge, Skills, Abilities, Training, and Experience:
Excellent technical writing and oral communication skills required. A working knowledge of general analytical methodologies (HPLC, GC, TLC, UV, NMR, IR, MS, wet chemistry, and cGMP/GLP) required, and a thorough understanding of basic organic chemistry a plus. Knowledge of USP reference standards and testing methods or pharmaceutical industry in-house reference standards qualification highly desirable. Working knowledge of relevant computer applications, especially Microsoft Word, Excel and Oracle ERP, required.
Authorities:
Review of the projects, Prepare comprehensive reports.
Additional Information:
Experience: 5-7 years
Tracking Code: 262-679
Location: Hyderabad, Andhra Pradesh, India
Education: M.Pharm, M.Sc, Ph.D
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
End Date: 15th November, 2014
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