Acts as a leader, mentor, and back-up for supervisor as needed. Provides in-depth analyses in a chemistry or microbiological environment by independently selecting methods, techniques, and evaluation.
Performs high-level analytical methods for complex testing on raw materials, samples, stability, environmental, production intermediates, environmental monitoring, sterility tests, growth promotion, microbial limits tests, and / or and antimicrobial effectiveness tests.
Supports internal development and / or manufacturing operations. Analyzes, resolves issues, documents, and communicates test results.
Essential Functions :
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, microbiological, 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 of leads the writing of SOPs, policy manuals, and other instructional documents. Oversees cleanliness and organization of work area, instrumentation, and testing materials.
Cleans HPLC and dissolution systems after use.
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 microbiological samples.
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.