Chemists II, QC Job in North Carolina (NC), Laboratory Career, Full Time Jobs in Novartis Pharmaceuticals
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Chemists II, QC job in Wilson

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Novartis Pharmaceuticals jobs
North Carolina (NC), Wilson
Job Code:  246715BR
Employer:  Novartis Pharmaceuticals
Category:  Laboratory
Job Type:  Full Time

Location
Country:  United States
State:  North Carolina (NC)
City:  Wilson
Map: 
09/14/2018

Description
Independently perform small molecule pharmaceutical chemistry development, validation, report creation and analytical testing as assigned, to support generic pharmaceutical manufacturing site operations and development. Perform technical support activities for materials and products as required, for small molecule pharmaceutical product development and testing execution. Responsible for HPLC/UPLC method development and method validation for pharmaceutical compounds. Perform troubleshooting and investigative work related to OOS (Out of Specification), OOE (Out of Expectation), OOT (Out of Trend) as required. Independently manage analytical project execution with leadership role for a team of chemists to ensure project and site commitment dates are met. Provide solutions to technical problems related to small molecule pharmaceutical chemistry. Develop, validate, and troubleshoot chromatographic methods for testing of samples, including Active Pharmaceutical Ingredients and finished products. Identify technical and compliance issues and work with management on implementing solutions. Perform analytical testing such as Assay, Related Compounds, Content Uniformity, Blend Uniformity and Dissolution on stability and finished products. Provide data analysis and report results in LIMS (Laboratory Information Management System). Perform enhanced testing related to validation and optimization such as Continued Process Verification, Process Performance Qualification and Process Qualification. Utilize, diagnose and troubleshoot analytical instrumentation such as HPLC (High Performance Liquid Chromatography), GC (Gas Chromatography), UV-Vis spectrophotometer, Karl Fischer Apparatus, Dissolution apparatus. Evaluate laboratory results critically, comparing to established specifications, acceptance criteria, and historical trends. Drive continuous improvement initiatives within Quality Control. Follow established procedures and develop new procedures based on SOPs and cGMP (current Good Manufacturing Processes) compliance requirements and appropriate scientific rationale. Maintain accurate records related to testing activities, and prepare timely summary reports of data. Review peer work and laboratory data to verify accuracy and compliance with SOPs and cGMP.Candidates must have a Master's degree in Chemistry or Pharmaceutical Science and minimum of 6 months of industry or research experience in small molecule pharmaceutical chemistry. Must have experience in: developing and validating HPLC methods; developing, validating, and troubleshooting chromatographic methods for testing of samples; diagnosing and troubleshooting analytical instrumentation such as HPLC; small molecule pharmaceutical analysis using analytical instrumentation such as HPLC, UPLC, UV-Vis spectrophotometer, Karl Fischer Apparatus, Dissolution apparatus; pharmaceutical analytical testing for Assay, Related Compounds, Content Uniformity, Blend Uniformity and Dissolution on stability and finished products; testing in compliance with cGMP requirements.

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