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Post: Scientist III- RSE
Summary of the Position
This is a non-supervisory position in the Reference Standard Evaluation department, responsible for oversight and successful implementation and completion of all activities pertaining to a portfolio of Reference Standards (RS), Pharmaceutical Analytical Impurities (PAI) and Certified Reference Materials (CRMs) or any other physical materials USP intend to develop. The position is expected to contribute majorly to PAI activities.
It is more of an operational and tactical role. This incumbent is responsible for, including but not limited to, timely preparation of procurement specifications, collaborative testing protocols for RS, APIs, and CRMs, providing technical assistance for collaborating labs, analytical data review, preparation of scientific/technical reports, Certificates, Product Information Sheet (PIS), defining and preparation of packaging configuration, Quality Control testing instructions, resolving technical issues.
• Responsible for managing the development of PAIs by working in collaboration with internal and external stakeholders/partners as necessary
• Item creation, reviewing the data package from partners, preparation of packaging and labeling forms (PLF)
• Preparing the documentation including, but not limited to, the test protocol, PAI report, and product information sheet.
• Communicate with internal stakeholders and external partners as and when required
• Addressing customer queries and complaints promptly after doing necessary investigation
• To have the ability to do “Problem-solving” at any step of the development process Contribution to regular Reference Standard development process as and when required, that involves
• Responsible for timely preparation of procurement specifications and 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 Reference Standard Candidate Evaluation Package (RSCEP), preparation of packaging and QC testing instructions, and assign periodic re-test intervals. Independently maintains successful scheduling operations, necessary documents, and complete and accurate information; and addresses quality issues to ensure availability of reference standards in a complex portfolio.
• To have a discussion with Scientific Liaison (SL) and Expert Committee (EC) members during new monograph or monograph modernization processes. Participating in peer review of draft monograph before submission to Pubs.
• To Draft product planning documents (PPD), coordinate with labs, and review/interprets data from international collaborative studies.
• Submits collaborative study summary reports to review and subsequent approval for each RS lot. Addresses the concerns of balloters to achieve successful approval of RSCEPs.
• To have the ability to do “Problem-solving” at any step of the RS development process.
• To produce quality documents (RSCEP, Addenda, TP) with minimum comments from RSTO and no “Major” observation from QA.
• To Coordinates for any additional necessary testing and assist other staff members in addressing the comments.
• To provide correct guidance on the interpretation of test data, Propose and design studies to obtain necessary data to resolve complaints.
• 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.
• Performs and participates in other related duties as assigned.
• Ph.D. in Chemistry / Pharmacy from a recognized University. Minimum of 0-2 years of Pharmaceutical industry experience
• MSc / MPharm from a recognized University. Minimum 7-8 years of Pharmaceutical industry experience Preferred Qualifications
• Prior knowledge of working with and/or qualifying reference materials
• Adequate laboratory experience to handle sophisticated analytical equipment
• Ability to read and interpret spectroscopic analyses data (NMR, IR, MS)
• Ability to handle multiple priorities in a fast-paced environment.
• Excellent written and verbal communication skills.
• Ability to operate independently where appropriate, yet understand when to escalate issues and how to establish effective working relationships
• Project Management skills. Must have the ability to prioritize and manage multiple, concurrent projects in a fast-paced and high-volume environment with changing deadlines and priorities
• Able to work flexible hours when needed to meet the project timelines
• Strong skills in troubleshooting, and solving technical problems
• Experience with, and knowledge of the USP-NF is preferred.
• Basic knowledge/familiarity with statistical analysis
Experience : 0 to 8 years
Qualification: Ph.D, M.Sc, M.Pharm
Industry Type : Pharma / Healthcare / Clinical research
Functional Area: RSE
End Date: 30th August 2022