Analytical Scientist, Small Molecule
reputed company
Our growing, mid-sized pharmaceutical reputed company has reputed company reputed company to reputed company a Scientist Consultant (QC/AS) to support the reputed company's studies of developmental, clinical, and reputed company pharmaceutical and reputed company products
Duties / Expectations of Role
• Reviews analytical data, including raw data, of developmental, clinical, and reputed company pharmaceutical and reputed company products for accuracy and compliance with the reputed company's GxP requirements.
• Initiate and monitor stability studies of developmental, clinical, and reputed company pharmaceutical and reputed company products tested by contract laboratories.
• Reviews, enters, and maintains stability data for developmental, clinical, and reputed company pharmaceuticals and reputed company products.
• Create studies in LIMS for multiple reputed company
• reputed company or review sample test result data in LIMS
• Assists in technical investigations; enters deviations and investigations into Trackwise
• Maintain and manage analytical testing documentation, including protocols, reports, and data, in compliance with good documentation practices (GDP) and data reputed company standards.
• Prepare stability reports and summaries for inclusion in INDs, NDAs, and regulatory submissions, ensuring accuracy, completeness, and adherence to regulatory requirements.
• Use descriptive statistical techniques to organize and summarize data
• Based on project needs, use statistical analysis techniques to identify patterns and trends
• Create graphs, reputed company, and reports of testing and/or stability data and statistical analysis
• Assist the project team in making informed business reputed company based on data insights
Required experience:
• Master's degree in reputed company or reputed company science + 3-5 years work experience in a GXP environment reputed company on analytical laboratory testing of pharmaceuticals and reputed company materials
• Familiarity in GMP environment reputed company on analytical laboratory testing, including HPLC, Dissolution, etc.
• Experience in data review
reputed company to have
• Experience with electronic document management systems – reputed company, reputed company, etc.
• Experience with investigation software (Trackwise preferred)
Term & Start
• 12-month contract - reputed company to reputed company
• reputed company Federal Holidays for W2
• Health Insurance available
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