This role is located in our Greenville, North Carolina facility. Relocation assistance has been approved for the successful candidate.
The Scientist 4 acts as a leader, mentor, and back-up for the supervisor as needed. Providing in-depth analyses in a chemistry environment, they independently select methods, techniques, and evaluation to perform high level analytical methods for complex testing on raw materials, samples, stability, and production intermediates. The Scientist 4 supports internal development and/or manufacturing operations, and makes detailed observations and analyzes, resolves issues, documents, and communicates test results.
Interprets, verifies and approves analytical data. Leads the development of quality products through participation and representation on group and department level project teams and mentoring junior team members. Advises on current best practices, challenges, and industry trends.
- Conducts high level critically complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, and stability samples by internally developed and compendial test methods.
- Oversees 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 and takes steps to resolve them.
- Maintains and troubleshoots analytical instrumentation as needed. Performs audits on equipment periodically to verify proper calibration and use. Oversees corrections.
- Leads the development of 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. Acts as the main contact and interacts with clients directly.
- Oversees the preparation and filing of regulatory documents in support of internal projects. Provides communications with outside departments, corporate sites, agencies, and clients.
- Manages the coordination and leads the writing of SOPs, policy manuals, and other instructional documents.
- Oversees the cleanliness and organization of the 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. Master’s degree in Chemistry or Biology preferred.
- Typically requires a minimum of 8 years of experience performing tests or analyses for pharmaceutical raw materials, finished products, or samples.