Our Scientist 1 role provides routine analyses in a chemistry environment by following standard practices. Performs
analytical methods as assigned for testing on samples, stability, environmental and production
intermediates. Supports internal development and/or manufacturing operations. Makes detailed
observations and reviews, documents, and communicates test results.
1. Conducts routine chemical and physical testing of pharmaceutical finished products, intermediates and stability samples by internally or externally developed and compendial test methods.
2. Executes validated test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, LC/MS, dissolution, spectroscopy, and/or traditional wet chemical testing.
3. Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product
4. Performs daily instrument calibrations / verifications as required.
5. Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems.
6. Assists in preparing regulatory documents and other communications with outside agencies, clients, and/or
colleagues from other corporate sites.
7. Contributes to writing of SOPs if needed.
8. Cleans and organizes work area, instrumentation, and testing materials. Cleans HPLC and dissolution systems after use.
9. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by
company and facility standards.
Bachelor’s degree in physical science, preferably in Chemistry or Biology.
Typically requires no previous related experience. Experience performing chemical tests with chromatographic, spectroscopic, or other analytical technique preferred.
Good knowledge and understanding of basic instrumental technologies. Knowledge of qualitative and quantitative
chemical or microbiological analysis. Awareness of quality and regulatory requirements in the pharmaceutical
industry. Good problem solving skills and logical approach to solving scientific problems. Demonstrable
interpersonal and communication skills (both oral and written). Ability to read and interpret technical procedures
and governmental regulations. Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques.