The U.S. Pharmacopeial Convention (USP) Scientist III, Analytical Research and Development in Hyderabad, India
Scientist III, Analytical Research and Development
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.
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.
Job Category Scientific