When you’re part of the team at ThermoFisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. How will you make an impact? Acts as a leader, mentor, and back-up for supervisor. 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. What will you do? 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. 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. Makes determination to resolve out-of-specification or unexpected results and analytical and product problems and takes steps to resolve them. Performs audits on equipment periodically to verify proper calibration and use. 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. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. How will you get here? Education Bachelor’s degree in physical science, preferably in Chemistry or Biology or Masters degree in Chemistry or Biology preferred. Experience Requires a minimum of 8 years of experience performing tests or analyses for pharmaceutical raw materials, finished products, or microbiological samples Knowledge, Skills, Abilities Expert knowledge and understanding of chemistry and analytical instrumental technologies. Expert knowledge of qualitative and quantitative chemical analysis. Excellent understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry. Advanced problem solving skills and logical approach to solving scientific problems. Excellent proficiency with HPLC, GC, LC/MS and Dissolution techniques (method development and validation). Excellent interpersonal and communication skills (both oral and written). Expert presentation skills to present information to customers, clients, and other employees. Excellent leadership skills. Ability to read, analyze, and interpret technical procedures and governmental regulations. Ability to write standard operating procedures and policy manuals. Ability to respond to complex inquiries or complaints from customers or regulatory agencies. Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance, and correlation techniques. Ability to mentor junior team members. Bilingual (Spanish & English
