Senior Analytical Scientist
The individual is responsible for performing and leading methods development, chemical and physical assays in support of pharmaceutical development projects. The individual will support the requirements of the stability program, method validation and process development program. The scientist will also perform project management or share with the Product Development Scientist the responsibilities of project management.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Include the following. Other duties may be assigned.
- Develop analytical methods for drug substances, preservatives and degradation/impurities in the finished product. Validate new analytical methods in accordance to Akorn, Inc. procedures and FDA regulations. Maintain Lab equipment and keep all the records up-to date.
- Develop and validate stability indicating assay procedures for pharmaceutical chemicals and finished dosage forms independently or closely working with the principal scientist as necessary.
- Perform testing of samples as required to support product development, regulatory submissions and the l stability program. Perform laboratory work to support product or process troubleshooting, special investigations and product complaints with sufficient supervision. Assist in the general operation of the Research & Development analytical laboratory, including maintenance of Standard Operating Procedures (SOP’s), training and equipment validation or maintenance.
- Perform laboratory work to support method validation or investigations. Assist performing validation of new equipment and the maintenance of the existing analytical equipment. The individual will participate in the writing of stability reports, product development reports and product specifications. Maintain accurate and complete laboratory records as required by company policy and Good Manufacturing Practices (cGMP) requirements and Good Document Practices (cGDP).
- Assist formulation or other analytical scientists in the testing or preparation of drug products and samples. Set and accomplish product development timelines working closely with formulation scientist. Perform other duties as deemed necessary by the department management.
- Design, develop, conduct and provide preliminary interpretation of study results with high level of independence.