Thermo Fisher Scientific Scientist IV-Analytical Development Project Representative in Cincinnati, Ohio
Title: Scientist IV-Analytical Development Project Representative
Work Location: Cincinnati, OH
When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world
Analytical Development Operations Representative on client project teams. Provides technical input and support for the internal team and the customer. Interacts with customers and works with internal team to set timelines, understand and schedule work requests, define and resolve issues, and communicate results. Recognizes and solves complex, non-routine analytical and product problems independently.
Provides technical leadership in the application of analytical sciences to the development of customers’ pharmaceutical products. Provides leadership in project teams and customer relationships. Manages multiple projects and day-to-day activities while contributing to a team atmosphere.
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
Attends customer meetings and is the analytical technical representative to set timelines, understand and schedule work requests, define and resolve issues and communicate results.
Clearly and accurately communicates the results of work by creating documentation of the testing and obtained results. Reports results in accordance with prescribed lab procedures and systems. Acts as the main contact and interacts with customers directly.
Provides technical input and approval of method validation documents related to test methods 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.
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.
Subject matter expert to assist the team supervisor with investigations for out-of-specification or unexpected results and analytical and product problems.
Contributes to the preparation and filing of project regulatory documents. Communicates with outside departments, corporate sites, and customers.
Participates and contributes to safety programs, department and customer meetings, and in maintaining an orderly and safe laboratory environment.
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 or PhD degree in Chemistry preferred.
Minimum of 8 years experience in the pharmaceutical industry, analytical development or quality control.
Equivalent combinations of education, training, and relevant work experience may be considered.
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.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.
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