Job in The United States Pharmacopeia Scientist II & III – Synthetic Lab (Product Development) | 2 openings
The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years.
Post: Scientist II & III – Synthetic Lab
This is a non-supervisory position responsible for route validation, preparation, isolation and purification of a variety of impurities and chemical compounds for drugs.
Roles and Responsibilities:
* Responsible for carrying out literature search to arrive at various synthetic pathways of the organic compounds of interest by which a candidate material can be synthesized.
* Responsible in synthesis of organic compounds by various routes of synthesis and name reactions , product identification and purification through various techniques.
* Responsible for performing R&D of the synthetic schemes and validate the rout of synthesis.
* General Material balance, Process Flow Diagrams (PFD), Recovery of solvents, Selection of equipments etc.,
* Characterization of compounds based on IR, NMR, Mass Spectra, Elemental analysis etc.
* To execute and completes the projects as per the time lines.
* Ensuring that the Chemicals, equipments and glass wares etc are available for the projects and forward the purchase requisitions.
* Periodic check of the assigned equipments to ensure that equipment is in good condition.
* To follow QMS systems of USP.
* Responsible for preparation and review of SOPs, Protocols, reports etc.
* Responsible for review the records and documents.
* Responsible to ensure the calibrations of the equipments are as per the schedule.
* Responsible for preparing, executing and completing IQ/OQ/PQ of new instruments.
M.Sc in Synthetic organic chemistry with about 6-8 years experience in medicinal chemistry and pharmaceutical process R&D.
A Strong background in synthetic organic chemistry. Having Ph.D would be an added advantage.
Should have worked directly within cGMP facilities engaged in the manufacturing bulk active pharmaceutical ingredients (APIs) or their finished dosage forms. Should have exposure to GMP/GLP environment and documentation procedures. Have good Practical, Documentation & Presentation Skills. Hands on experience in total synthesis of Specialty Chemicals, Contact Research Projects, API’s and Drugs products etc Familiar with General Material balance, Process Flow Diagrams (PFD), Recovery of solvents, Selection of equipments, etc
Knowledge, Skills, Abilities, Training and Experience:
Knowledge of GMP/GLP/ISO laboratory requirements. Familiar with a variety of synthetic chemistry principles, theories and practices, including separation science. Able to carry out multiple small scales reactions at a time and validate the route of synthesis. Conservent to carry out different types of chemistries. Excellent written and oral scientific communication skills. A working knowledge of common USP/NF/FCC analytical methods and procedures. Exposure to various routes of synthesis and characterization techniques such as NMR, IR, Mass Spectra, XRD, DSC, and other analytical interpretations through HPLC, GC, FTIR, UV-Visible etc is desirable. Familiarity with ISO guidance on Reference Materials and an understanding of associated statistics and metrological principles.
Reference Standards Development and Testing Laboratory
Experience: 3-7 years
Education: M.Pharm, M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
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