The U.S. Pharmacopeial Convention (USP) Scientist I, CDL Master’s Degree in Chemistry (Analytical /
Organic) or Pharmaceutical Sciences
Summary of the Position
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.
This is a non-supervisory position in the Compendial
Development Laboratory (CDL) within Global Laboratory Operations. The incumbent
will be responsible for performing USP-NF/FCC method development and method
validation projects and maintaining safety and GLP environment in the lab. This
position is a component of USP’s core business and the incumbent is expected to
support monograph modernization initiatives.
USP promotes Diversity & Inclusion at Workplace and
encourages Equal Employment Opportunity and Affirmative Action
Roles and Responsibilities
Literature search for the assigned projects.
To ensure the projects requirements by coordinating with the
Group Leader and other stakeholders.
To involve in project execution, method development and
validation of assigned projects.
To acquire the knowledge on different drug products handling
and samples preparations.
Provides technical and scientific support in drug substance
and drug product analytical development.
Engage in project planning, execution, method development and
validation of projects according to set standards such as USP general chapters,
guidelines, SOPs and protocols.
Ensure the project updates are provided to the supervisor on
regularly.
To coordinate with Group Leader to complete assigned projects
within timelines.
Responsible for preparation and review of SOPs, Method
development and validation protocols, reports etc.
Responsible for on-line documentation and review of records
and documents.
To ensure that the calibrations of the equipment are
performed as per the schedule.
Responsible for preparing, executing and completing IQ/OQ/PQ
of new instruments.
To indent the required glass ware, chemicals and columns for
the assigned projects.
To maintain GLP & safety procedures while working in Lab.
Required Skills
Master’s Degree in Chemistry (Analytical / Organic) or
Pharmaceutical Sciences with 1-3 years of experience. Excellent technical
writing and oral communication skills required. Must be able to communicate
effectively with diplomacy and enthusiasm. Technical and analytical skills
required including the ability to interpret technical information. Must have
hands on experience in working with chemical methods and handling instruments
like HPLC, UHPLC, LC-MS, GC, GC-MS, IC, ICP-OES/MS, FTIR, UV-Visible. Should
have fair understanding of GLP regulations and exposed to external regulatory
audits
Required Experience
Master’s Degree in Chemistry with 1-3 years of experience.
Possess a fine understanding of USP/NF/FCC monographs/general chapters/general
notices. Exposure to GMP/GLP/QMS environment and documentation procedures and
champions the data integrity. Should be capable of performing analytical method
developments and method validations using modern techniques and protocols.
Good
analytical skills in handling method development and Validations for Food
ingredients and food products. Should have exposure to GMP/GLP environment and
documentation procedures. Awareness of ISO/IEC 17025 is desirable.
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