Analytical Scientist I
Perform method validation and troubleshooting for analytical test methods to support formulation development and stability study of prototype formulation and scale-up batches of products. Coordinate with QA/QC groups and contract manufacturers and laboratories for method transfer and supporting tests. Ensures the proper documentation of such methods. Prepare stability test reports, method validation/transfer protocols and reports. Accountabilities
- Evaluate and validate/verify appropriate analytical methods for new and existing products while meeting established project timelines.
- Perform analytical tests to support formulation development and stability study of prototype formulation and scale-up batches of products.
- Perform new raw material qualification activities to support developmental process.
- Keep accurate documentation of laboratory work, especially laboratory notebooks, analytical methods development, validation, and transfer to other departments, vendors, and regulatory documents.
- Generate analytical development reports in a timely manner.
- Calibrate laboratory equipment as needed.
- Review analyst Raw Data, protocol and reports.
- Ensure Project timelines are met.
- Perform equipment calibration on scheduled basis for Analytical Development laboratory
- Asist with PQ for Lab equipment when required
- Perform analytical methods evaluation and validation to demonstrate product or material characterization suitability.
- Tests new products or existing products to provide marketing and quality assurance support. Keep accurate records of analytical testing data and generate testing and analytical development reports. Provides technical support for manufacturing issues related to process and raw materials.
- Maintain accurate record of laboratory work, especially laboratory notebooks, analytical methods development, validation, and transfer to other departments, vendors, and regulatory documents.
- Writes, reviews, and approves technical protocols and reports as required.
- Perform other related duties as required.
- B.S. in Chemistry or related scientific discipline with at least 2 years of hands-on experience in industrial analytical laboratories.
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