This role is located in our Greenville, North Carolina facility. The Scientist 3 provides complex analyses in a chemistry environment by selecting appropriate methods with independent judgment and perform analytical methods for complex testing on raw materials, samples, stability, and production intermediates. The Scientist 3 supports internal development and/or manufacturing operations, and makes detailed observations and analyzes, resolves issues, documents, and communicates test results.
- Lead, design, and / or participate in method assessment, method transfer, and method validation activities.
- Verifies and processes analytical data. Facilitates development of quality products through participation and representation on group and department level project teams.
- Conducts complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, and stability samples by internally developed and compendial test methods.
- Leads the validation of 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 traditional wet chemical testing. Determines which methods will be used.
- Makes determination to resolve out-of-specification or unexpected results and analytical and product problems.
- Maintains and troubleshoots analytical instrumentation as needed. Performs audits on equipment periodically to verify proper calibration and use.
- Develops documentation processes. 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. Interacts with clients directly.
- Leads, prepares, and files regulatory documents in support of internal projects. Provides communications with outside departments, corporate sites, agencies, and clients.
- Coordinates and leads writing of SOPs, policy manuals, and other instructional documents.
- Cleans and organizes work area, instrumentation, and testing materials. Cleans HPLC and dissolution systems 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.
- Bachelor’s degree in physical science, preferably in Chemistry or Biology.
- Typically requires a minimum of 5 years of experience performing tests or analyses for pharmaceutical raw materials, finished products, or samples.
All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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