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.
Post: Scientist-I, Compendial Development Laboratory
Job Description
Function of the Position:
This is a non-supervisory position in USP-India’s Analytical Research & Development Laboratory. In this role, the Scientist - I works on projects including R&D for in process samples for synthetic chemistry support and 17025 analyses for ARD, RSL, Verification and Biologics. The Scientist I performs a variety of non-routine and routine analytical tests, including evaluation of reference standards, development or validation (as per requirement) of official methods, evaluation of packaging materials and stability studies, and general research in analytical chemistry.
Roles and Responsibilities:
-Responsible for operating, and maintenance of 500 MHz NMR instrument, recording and interpretation of NMR spectra for samples submitted by the Synthetic Organic Chemistry Lab, Reference Standards Lab, Biological & Biotechnology Lab, and other sources as per ISO 17025.
-Develop appropriate NMR methods for identified of certain projects from time to time
-Work in open access instruments to support a team of ARD scientist and deliver result in a timely manner
-Responsible for small and large molecules structure elucidation using NMR spectroscopy
-Support to synthetic R&D projects from start to completion as per ISO 9001.
-Assist and maintain the safety aspects in the laboratory
-Help develop Standard Operating Procedures and policies in ARD Lab
-Coordinate with Quality Assurance staff to ensure the implementation of corrective actions
-Performs other related duties as required
-Planning for ISO-9001 & ISO-17025 Recertification Verification of Protocols.
Education and Experience:
Master’s degree in Analytical Chemistry / Organic Chemistry with minimum 2-4 years experience in handling the NMR spectrometer. Extensive NMR knowledge both in running the equipment and interpretation of results. Must have experience in small molecule structure elucidation using NMR. Experience of wet chemistry and other analytical testing aspects would be an added advantage. NMR experience on biological molecules such as peptides, proteins and vaccines would be an added advantage.
Knowledge, Skills and Abilities:
Expertise with Bruker & Varian NMR software- automation software & hardware including cryo-probes. Must be familiar with electronic notebook documentation of experimental procedures. Must possess a strong work ethic and a solid record of problem solving and technical results. Knowledge of solid state NMR and multinuclear NMR operations is an advantage. Comprehensive understanding of the science involved in the development of synthetic organic molecules and analytical chemistry. ACD & Chemdraw software’s handling is added advantage. 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 must. Understanding of GMP / ISO-IEC 17025 Guidelines is a requirement.
Additional Information:
Experience: 2-4 years
Tracking Code: 524-679
Location: Hyderabad, Andhra Pradesh, India
Education: Master’s degree in Analytical Chemistry / Organic Chemistry
Industry Type: Pharma/ Healthcare/ Clinical research
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