This is a mid-level chemist position, which in association with FDA requirements, SOP's and cGMP's is responsible for performing method transfer, method development and validation studies on drug substances and drug products.
Execute all testing or part of testing described in the method transfers, verification and validation protocols and prepare validation reports
Prepare validation/verification protocol, reports, development reports and QC methods
Manage the analytical data generated during the testing and to maintain accurate laboratory records
Perform miscellaneous lab procedure to support the method development
Analysis of development samples and reporting the results
Conduct literature search for chemistry, degradation pathways, methods and other relevant matter for the selected projects
Follow cGMP, GLP and current safety guidelines
Review technical documents for drug substances and drug products
Develop analytical methods for assays, impurities, residual solvents and residual swab analysis
Prepare, update and review SOP's
Assist to prepare ANDA submission documents
Able to reach, push, bend and/or lift up to 50 lbs frequently
Perform other duties as assigned
Requires knowledge in chromatography, spectroscopy, FTIR, sample preparation, titration and wet chemistry
Interpretation and troubleshooting of chromatography
Requires advance knowledge of computer usage and lab equipment
Multiple priority and multiple task orientation
Must have ability to interpret analytical data and document analytical details appropriately
Minimum 10 years total pharmaceutical analysis experience with minimum 5 - 6 years experience in method development or validation.
Bachelors degree in chemistry or other appropriate Science background
Caraco Pharmaceutical Laboratories - 12 months ago
Caraco Pharmaceutical Laboratories, Ltd. (Caraco) is engaged in the business of developing, manufacturing, marketing and distributing generi...