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Job Location | Hyderabad |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | Bio Tech / R&D / Scientist |
EmploymentType | Full-time |
Senior Scientist I Analytical Research and Development Tracking Code IND 161
Job Description This is a supervisory position in USP-India s Analytical Research & Development Laboratory. In this role , the Senior scientist-I works on projects including Analytical Method Development for in process samples for synthetic chemistry support and compendial Analytical method validation when applicable. The Senior scientist-I reviews/monitors a variety of non-routine and routine analytical tests , maintains safety & GLP environment in the lab 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 Develop appropriate HPLC and other methods for identified of certain projects from time to time Review of analyses of samples as per monograph / in-house procedures including reaction monitoring. Prepare development reports for Synthetic Support projects (USP-NF). Involve in project acceptance & approvals. Execute projects as per the approved test protocols if assigned. Responsible for preparation of SOPs , protocols , reports , etc. Ensure the projects requirements by coordinating with the purchase department. Coordinate with lab scientists to complete ARD projects within timelines. Responsible and operating and maintenance of MS (ion-trap , triple Quad MS) instruments , analysis and interpretation of MS spectra of the chemical compounds Prepare or review of the lab reports and documents Ensure that the calibrations of the equipment s are performed as per the schedule. Prepare , execute and complete IQ/OQ/PQ of new instruments. Indent the required glass ware , chemicals and columns for the ARD projects. Maintain GLP & implement safety procedures while working in Lab. Perform other Projects whenever free from ARD activities. Work in open access instruments to support a team of synthetic scientist and deliver result in a timely manner and support the synthetic R&D projects Assist in the development and implementation of safety projects impacting all USP Laboratory personnel Participates in USP cross-functional teams as appropriate 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 Responsible for internal , method , ISO-9001 & ISO-17025 audits
Required Skills M.Sc. in Analytical Chemistry / Synthetic Organic Chemistry , from a well-recognized University in India or abroad and required not less than about 8-10 years actual hands-on experience for analytical instruments. Experience in analytical testing and development with focus on process analytical chemistry. Exposure to GMP/GLP environment and documentation procedures required. Ability to perform analytical method developments and method validations as and when required
Required Experience Must have hands on experience in working with chemical methods and handling instruments like HPLC , GC , FTIR , UV-Visible , wet chemistry , etc. A comprehensive understanding of the science involved in the development of synthetic organic molecules and analytical chemistry. Must be able to communicate effectively with both internal and external customers. 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. Working knowledge of computer applications , such as MS Word and MS Excel are required. 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 a requirement .
,Keyskills :
hplc validation api research documentation penaccess syntheticorganicchemistry analyticalmethodvalidation analyticalmethoddevelopment researchdevelopment wetchemistry standardoperatingprocedures iso9001