United States Pharmacopeial Convention (USP)
Scientist III, Analytical Research
and Development (Preparative HPLC)
Hyderabad, India
Description
The U.S. Pharmacopeial Convention (USP) is a scientific
non-profit 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. USP promotes Diversity &
Inclusion at Workplace and encourages Equal Employment Opportunity and Affirmative
Action
Summary of the Position
This is a non‐supervisory position in ARD lab performing
Isolation and Characterization of impurities, analytical support and
maintaining Safety & GLP environment in the lab. In this role, the
Scientist works on isolation/ purification of known and unknown
impurities/compounds by preparative HPLC including Characterization of
molecules for synthetic chemistry and reference standard development.
Roles and Responsibilities
Coordinate with the
supervisor to maintain the Lab as per GLP and safety practices.·
Execute the
Isolation and Characterization projects under the supervision of the
supervisor.·
Ensure the projects
requirements by coordinating with the supervisor.·
Coordinate with the
supervisor for the project execution and delivery.·
Upkeep the
Preparative HPLC, Mass and NMR Spectrometer.·
Coordinate with
supervisor to meet the set timelines for projects completion.·
Responsible for
preparation and review of SOPs, Protocols, reports, etc.·
Responsible for
review the records and documents.·
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.·
Ensure the lab requirements like glassware, chemicals and columns for the Isolation and
Characterization lab.· Ensure to follow
USP Policies and Procedures.·
Prepare for
ISO‐9001·
& ISO‐17025 audits and related activities.
Proven track record of consistently delivering projects on
time and with high quality.
Proficient with
pharmaceutical testing requirements and test protocols involving compendial
methods for reference materials (USP, BP, EP, etc.).·
Expert in HPLC and
GC analysis and troubleshooting, proficient in other related analytical
instrumentation (IR, KF, UV, and thermal analysis techniques etc.).·
Expertise with
Waters·
& Agilent Perp.HPLCs, NMR and LCMS software & hardware’s including
extraction procedures and must be familiar with electronic notebook
documentation of experimental procedures.
Must be able to
communicate effectively with both internal and external customers. Must possess
a strong work ethic and a solid record of problem solving and technical
results.·
Knowledge of
various extraction methods to purify the compounds is an advantage. A
comprehensive understanding of the science involved in the development of
synthetic organic molecules and analytical chemistry.·
Excellent technical
writing and verbal communication skills are required. Good interpersonal skills
and proven ability to function in a team‐oriented environment are necessary.
Proven self‐effectiveness· skills are a must. Understanding of GMP / ISO /IEC
17025 Guidelines is desirable.
M.Sc. in Analytical Chemistry / Organic Chemistry, from a
well‐recognized University in India or abroad and required not less than 6‐8
years’ experience in purification and characterization of unknown and known
compounds using preparative HPLC and other analytical instruments.
Extensive
Prep.HPLC, NMR, LCMS and HPLC knowledge both in running the equipment and
interpretation of results and characterization of the compound by spectral
techniques (NMR, MASS and IR). Must have experience in Method development and
purification of compounds by prep HPLC.Ø
Good technical
writing and verbal communication skills are required. Good interpersonal skills
and proven ability to function in a team‐oriented environment are necessary.
Understanding of GMP / ISO‐IEC 17025 Guidelines is a requirement.Ø
Job Category Chemistry
& Scientific Standards
Job Type Full-Time
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