Summary of the Position: The Analytical Scientist will be expected to develop and validate new analytical methods with minimum to no supervision as well as to provide technical support to other corporate groups including Quality Control, Quality Assurance, and International Business.
Roles and Responsibilities:
- Analytical Scientist reports to Analytical Chemistry (AC) Management.
- Performs Quality Control testing and data review to support timely release of product in weekly basis.
- Effective development, optimization, and validation of scientifically sound analytical methods to ensure analysis and prompt release of raw materials, finished products, and stability studies.
- Proficient in Empower Software and other laboratory software use in QC environment for chromatographic, spectroscopic methods as well as wet chemistry.
- Assess testing methodologies and their application to different sample matrix, instrumentation and will include evaluation of testing results from contract laboratories to be sure that the agreed methods and testing parameters were properly followed.
- Maintains current knowledge of latest technological and scientific trends and serves as an analytical science resource for the rest of the group. Mentor and train chemists in the proper execution, including interpretation of validation studies.
- Responsible for producing hazardous waste from it point of generation. Managing all produced in accordance with RCRA and SCDHEC regulations to include: proper containers, accumulation, labeling, marking, and storage.
- Perform other assigned duties and follow verbal and written instructions issued by supervisor or designee related to meeting company goals and objectives.
- Communicate effectively with other departments within the organization and function within a team environment.
- Regular attendance is required.
Minimum Requirements:
- Able to develop analytical methods for chromatographic, spectroscopic, titrimetric, and wet chemistry analyses.
- Must be proficient on laboratory instrument trouble shooting.
- In-depth knowledge of strategies of analytical method development and specification setting for raw materials and finished products.
- Knowledge in most of laboratory instrumentation such as FTIR, HPLC, ICP, GC, UV-Vis, LC-MS, GC-MS, ICP-MS, HPTLC and test methods.
- Knowledge in the characterization and elucidation of botanical compound structures by study of the compound structure, spectroscopic methods, and Mass spectrometry.
- Proficient in the selection of analytical columns for chromatographic analyses, proper techniques or technologies and the selection for proper reagents to design effective analytical methods in timely manner.
- Experience in effective sample preparation techniques to support high number of samples for testing such as liquid-liquid extraction, derivatization, chemical manipulation, and mechanical manipulation.
- 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.
- Demonstrated aptitude to function in a dynamic fast-paced environment.
Education and Experience
- A Bachelor's degree with 10 years of experience in validation and development of analytical methods for nutraceuticals and/or pharmaceutical samples in a GMP environment. A Master's degree and a minimum of 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.
Supervisory Responsibilities: None