QC Scientist II
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
Preferred candidates should provides technical support and leadership for method transfer, method and process improvement and problem solving and improvement for Quality Control related issues. Leading decision making through technical and statistical analysis. Performs analytical testing and assay validation in collaboration with R&D, Engineering, QA and Manufacturing. Lead effort in method and process improvement. Assists in the analysis, review and release of QC data for the purpose of final product approvals. Leads or provides support to develop, write and reviewing new and existing SOPs. Leading in-house stability studies and other improvement efforts.
Requires a BS or higher in Chemistry, Biology, Biotech or related fields, with 3-5 years of experience in a Biotech/Pharma/Clinical QC environment.
Methods development, validation and technology transfer, experience required. Compliance knowledge with ISO9001, ISO13485, ICH Q2, GMP/GLP requirements preferred.
Working knowledge of on of the followings required:
Molecular biology assays (microplate assays, microplate luminometers, microplate fluorimeters) .
HPLC systems and methods(AKTA/Unicorn/Agilent/PE HPLCs)
DNA Sequencing/Fragment Analysis, and Capillary Electrophoresis equipments
Knowledge of Process Excellence, Six Sigma and Lean Manufacturing is a plus.
Must be able to work independently as well as work with a diverse team. Ability to prioritize assignments and to manage multiple projects in a time-sensitive environment is essential. Knowledge of SAP or similar inventory control systems desired. Familiar with Microsoft Excel and Word. Excellent oral and written communication skills are required to be effective in this role.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.