R&D / Manufacturing Scientist II

at  Thermo Fisher Scientific

JOB DESCRIPTION

Do you have a passion for innovative ideas and ground-breaking discoveries? With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you’ll help solve some of the world’s toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.

EDUCATION

Bachelor’s degree in chemistry or related field

EXPERIENCE/QUALIFICATIONS

• 5+ years of experience working in a laboratory preferred (GLP or GMP/cGMP environment preferred)
• 5+ years of demonstrated ability with analytical instrumentation, such as HPLC, GC, spectroscopy, GC/MS, LC/MS
• Extensive knowledge and understanding of chemistry and analytical instrumental technologies
• Knowledge of qualitative and quantitative chemical analysis
• Considerable knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry
• Understanding of medical terminology, clinical data, and Good Manufacturing Practices (GMP)

SKILLS & ABILITIES

• Problem solving skills and logical approach to solve scientific problems
• Excellent interpersonal, communication (both oral and written), and presentation skills
• Ability to read, analyze, and interpret technical procedures and governmental regulations
• Ability to write standard operating procedures, simple protocols, and reports
• Apply mathematical operations, to such tasks as determination of test reliability, analysis of variance and correlation techniques.
• Work on multiple projects simultaneously

• Conduct routine and non-routine chemical testing and method development/qualification for pharmaceutical raw materials, in-process samples, and pharmaceutical ingredient samples by internally developed and compendial test methods
• Execute developmental and validated test methods using HPLC, GC, spectroscopy, GC/MS, LC/MS, and/or traditional wet chemical testing, and train other employees on these techniques
• Provide thoughtful technical review of data collected by other employees
• Recognize and report/investigate out-of-specification or unexpected results and non-routine analytical and product problems
• Communicate the results of work by documenting the testing/analysis and acquired results; record and report results of analysis in accordance with prescribed lab procedures and systems
• Assist in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites
• Write and review Analytical Methods, validation protocols, validation reports, and SOPs as needed
• Solve problems related to the processing of chemical procedures
• Perform daily instrument calibrations / verifications as required and weekly/monthly inspection of safety equipment