Summary of the Position
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), 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 in 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 specification, collaborative testing protocols for RS, PAIs, 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.
Roles and Responsibilities
The position is expected to contribute majorly in PAI activities that involves
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 labelling forms (PLF)
Preparing the documentation including, but not limited to, the test protocol, PAI report, product information sheet.
Communicate with internal stakeholders and external partner as and when required
Addressing customer queries and complaints promptly after doing necessary investigation
To have ability to do Problem solving at any step of 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 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 have 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), coordinates with labs, and reviews / 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 ability to do Problem solving at any step of 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 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 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 participate in other related duties as assigned.
PhD 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
Prior knowledge of working with and / or qualifying reference materials
Adequate laboratory experience to handle sophisticated analytical equipment’s
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 communications 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 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
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.
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 brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide.