Summary of the Position:
A qualified individual who has the understanding and knowledge of development of chromatographic, spectroscopic, titrimetric and wet chemistry methods. Implements strategies to ensure effective achievement of scientific objectives. Monitors and evaluates completion of tasks and projects.
Roles and Responsibilities:
- Has hands on knowledge and can begin the development and validation of scientifically sound analytical methods for Product release and stability testing.
- Familiarity with transfer of analytical methods to the QC department.
- Working knowledge of Empower Software, chromatographic, spectroscopic as well as wet chemistry.
- Aides in the timely preparation, review and approval of technical documentation.
- Maintains current knowledge of latest technological and scientific trends, and serves as an analytical science resource for the rest of the group.
- Can establish raw material and finished product specifications if and when necessary.
- Creates, reviews, and ensures compliance with Standard Operating Procedures.
- Perform other assigned duties as may be required in meeting company objectives.
- Communicate effectively with other departments within the organization and function within a team environment.
- In-depth knowledge of strategies of analytical method development and specification setting.
- Advanced understanding of experimental design, chemical theory and analytical instrumentation. Knowledge of statistical techniques, such as data trend analysis and design of experiments, is highly desirable. Proficiency in reviewing and interpretation of laboratory data.
- Detailed knowledge of principles of routine laboratory operations.
- Thorough working knowledge of industry regulations, FDA and ICH guidelines; experience implementing and maintaining adherence to pharmaceutical and/or nutritional supplement GLP/GMP is strongly desired.
- Proven ability to communicate effectively and cooperatively within all levels of an organization. Strong communication skills both verbal and written.
- Demonstrated aptitude to function in a dynamic fast-paced environment.
Education and Experience:
A Bachelor’s degree with 7 or more years of technical experience is desired. A Master’s degree 3-5 years of technical experience is preferred. Extensive experience may be accepted in lieu of an advanced degree. A degree in analytical chemistry, biochemistry, chemical engineering or related fields is strongly preferred. A need to work on the bench to accomplish tasks along with the Analytical Chemistry team.