US Pharmacopeia

Job Details

Description

Who is USP?

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.

At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

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)/Analytical Reference

Materials (ARMs) including but not limited to pharmaceutical analytical impurities, extractables &

leachables, polymers and certified reference materials (CRMs). This incumbent is responsible for the

timely preparation of procurement specification and collaborative testing protocols for all candidate lots,

technical assistance for collaborating labs, analytical data review and preparation of summary reports,

preparation of packaging and Quality Control testing instructions.

How will YOU create impact here at USP?

In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality,

safe medicine and improving global health through public standards and related programs. In addition, as part of

our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly

invests in the professional development of all people managers. This includes training in inclusive management

styles and other competencies necessary to ensure engaged and productive work environments.

The SIII/SIV position has the following responsibilities:

• Responsible for timely preparation of testing protocols for new/replacement reference materials,

technical assistance for collaborating labs

• To review the analytical data received from the Collaborators and to prepare summary reports,

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.

• Coordinate 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 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.

Who is USP Looking For?

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:

Scientist IV

• MSc in chemistry or related field with 8-10 yrs of experience (or) Ph.D. in chemistry or related

field with 3-5 yrs of experience

Scientist III

• MSc in chemistry or related field with 6-8 yrs of experience (or) Ph.D. in chemistry or related

field with 1-3 yrs of experience with the following skills

• Hands on experience in interpretation of results, characterization of the compound by spectral

techniques (NMR, MASS, and IR).

• Knowledge on chromatographic techniques (HPLC, GC)
• Ability to handle multiple priorities in a fast-paced environment.
• Excellent written and verbal communications skills.

Additional desired preferences:

• Ability to read and interpret spectroscopic analyses data (NMR, IR, MS etc.)
• Hands on experience on chromatographic techniques such as (HPLC, GC).
• Prior experience with materials characterization using a variety of analytical techniques.
• Prior experience with lab investigations.
• Stability studies exposure.

Supervisory Responsibilities:

NA

Benefits

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off

and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and

financial well-being is protected.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP

Read Full Description