Job Description

　　Position: Scientist III, Manufacturing Sciences

　　The ThermoFisher Manufacturing Sciences/Technical Operations in Frederick, MD is seeking an experienced candidate to join our diverse team. As a member of the team, you will work closely with Project Management and scientists within R&D, Manufacturing, Quality Assurance and Quality Control to drive excellence in new product introduction, technology transfer and continuous improvement.

　　What will you do?

　　As part of multi-functional team, lead technical transfer of processes from R&D or other sites to Manufacturing ensuring effective communication, timeline execution, issue resolution, and documentation in accordance the quality system requirements.Provide technical support for manufacturing process validation including the design and execution of studies, data analysis and preparation/review of technical protocols and reports.Lead the tech transfer of analytical methods to QC including the design and execution of method validations.Implement DOE and gage R&R studies to drive manufacturing robustness and repeatability.Identify and implement productivity projectsPerform testing such as fluorescent based assays, Next Generation Sequencing, PCR, Bioanalyzer, HPIC, HPLC or similar techniquesProvide technical and scientific support for any manufacturing process related events such as manufacturing deviations, technical issue resolution, change control and process optimization.

　　Education /Experience Requirements

　　Bachelor's degree or higher in Molecular Biology, Analytical Chemistry or related field.Minimum of 4-6 years related experience, work in with FDA regulated products preferredSound understanding of analytics, scale-up principles and process validationExperience with molecular biology and analytical techniques such as qPCR, HPLC, HPIC, Bioanalyzer, UV-VIS spectroscopyAbility to address intricate technical issues and in-depth data analysis in a multi-functional teamStrong systems/process orientation with proven analytical thinking, problem-solving skills.Highly detail oriented with strong interpersonal skills