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Scientst, Analytical Development

Job Description

Purpose:
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.

Essential Duties:

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

Core Competencies:

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

Work Experience:
Minimum 10 years total pharmaceutical analysis experience with minimum 5 - 6 years experience in method development or validation.

Education:
Bachelors degree in chemistry or other appropriate Science background

Company

Caraco Pharmaceutical Laboratories Ltd.

Job Code

State or Province

Michigan

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