Scientist
II, CDL (Excipients) @ The U.S. Pharmacopeial Convention (USP)
Job Description
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.
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
analytical method development and validations for USP/NF monographs 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.
Roles and Responsibilities
Search relevant literature for
the USP/NF monograph modernization projects.
Provide effective technical and
scientific expertise in analytical method development and validation of
excipients/ pharmaceuticals.
Plan individually the project
requirements and their completion within the time lines by coordinating with
the supervisor and team.
Responsible for preparation and
review of SOPs, protocols, reports, etc.
Preparation of development &
validation reports for respective USP/NF monograph modernization projects.
Ensure that the calibrations of
the equipment are performed as per the schedule.
Responsible for preparing,
executing and completing IQ/OQ/PQ of instruments.
Indent the required glass ware,
chemicals and columns for the CDL projects.
Maintain GLP & safety procedures
while working in Lab.
Presentation on the project pipeline
and outcomes with the management will be a part of job.
Required Skills
Master’s Degree in Chemistry
with 3-5 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.
Required Experience
Master’s Degree in Chemistry
(Analytical / Organic) or Pharmaceutical Sciences with 3-5 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
Job Location
Hyderabad, India
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