Duties/Responsibilities:

• Develop, optimize, and validate analytical methods for Assay/Blend Uniformity/Content, Uniformity/Impurities/Residual solvents and Dissolution.
• Provide analytical data to support drug product development.
• Perform HPLC and wet chemistry tests.
• Write analytical procedures, specifications, formal technical reports, and method validation protocols and reports.
• Conduct method validation and analysis of finished products, in-process materials, and raw materials to accord with the assigned specifications, methods and protocol.
• Record and interpret results.
• Review and verify chromatographic data, results, and calculations in notebooks/logbooks and report results.
• Evaluate analytical data, interpret results, and write reports.
• Perform analytical instrument maintenance, calibration, and troubleshooting.
• Maintain Pharmacopeial reference standard and impurity reference standards for method development and validation for ANDA submissions
• Serve as team lead to develop/validate analytical methods, and mentor Junior Chemists regarding analytical lab techniques.
• May undergo background checks and drug screening

Required Qualifications: 

• Must have Bachelors in Chemistry, Pharmaceutical Science, Biology, or related science field, 6 years relevant experience in pharmaceutical industry, and required skills (6 years’ experience). 
• In the alternative, must have Masters in Chemistry, Pharmaceutical Science, Biology, or related science field, 3 years relevant experience in pharmaceutical industry, and required skills (3 years’ experience). 
• Required skills include: using separation technology (HPLC/GC/IC) in pharmaceutical development; GLP/cGMP documentation; UV Spectroscopy, HPLC and GC instrumentation; and dissolution testing.

Location:  i3 Pharmaceuticals, LLC, Warminster, PA