Thermo Fisher Scientific Scientist III, Manufacturing Sciences (2nd Shift) in Frederick, Maryland
The Thermo Fisher Manufacturing Sciences/Technical Operations in Frederick, MD is seeking an experienced candidate to support lab automation and validation throughout manufacturing. The successful candidate will work in cross-functional teams to drive excellence in process design, new-product-introduction, technology transfer, problem solving, and root-cause analysis. The scientist will be involved execution of both method and process validations as well as continuous improvement efforts.
Provide technical support to enhance manufacturing robustness and repeatability
Support continuous improvement, new product development and method transfers.
Plan, schedule and performs testing of processes and reagents utilizing techniques such as fluorescent based assays, qPCR, dPCR and NGS
Participate in the design and execution of method and process validations.
Collaborate with R&D, QA, QC, and operations functions to ensure on-time, robust, and cost-effective transfer of new products/QC methods into Manufacturing
Collaborate with departments across the organization to resolve technical issues
Analyze data and communicate results in a team environment.
Participate in the drafting manufacturing documentation such as production SOPs
Troubleshoot issues/conduct root cause analysis and to recommend and implement corrective actions for processes
Maintains accurate records and documentation; responsible for the quality of project deliverables and documentation
Education /Experience Requirements
Bachelor's degree or higher in Molecular Biology or related field.
Minimum of 6 years industry experience (work with FDA regulated products preferred)
Strong bench skills and experimental design
Experience with analytical method and process validation in a regulated environment
Strong systems/process orientation with demonstrated analytical thinking, organizational skills and problem-solving skills
Experience with Lab Automation (liquid handling workstations, plate washers and other robotics)
Ability to design DOE studies, gage R&R study, JMP, and conduct appropriate data analysis a plus.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.