Thermo Fisher Scientific R&D / Mfg Scientist II in Greenville, North Carolina
Provides method development, validation or routine analyses in an Analytical Development and Chemistry/Bioanalytical Laboratory environment by following standard or industry best 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.
Conducts routine chemical and physical testing of pharmaceutical finished products, intermediates and stability samples by internally or externally developed and compendial test methods.
Develops and executes validated test methods for pharmaceutical intermediate or 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.
Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems.
Performs daily instrument calibrations / verifications as required.
Clearly and accurately communicates the results of work by creating documentation of the testing/analysis/development and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems.
Assists in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.
Contributes to writing or authoring of SOPs if needed.
Cleans and organizes work area, instrumentation, and testing materials. Cleans HPLC and other systems/instruments after use.
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.
Education & Experience:
Bachelor’s degree in physical science, preferably in Chemistry or Biology with 3 – 5 years previous related experience, Master’s degree with 2 – 3 years previous related experience or PhD with no previous experience. Experience performing method development and validation, chemical tests with chromatographic, spectroscopic, or other analytical techniques preferred.
Good knowledge and understanding of basic and advanced 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.
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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.