Scientist I, Formulations

at  Thermo Fisher Scientific

EDUCATION

• High shool diploma or equivalent required
• BS/BA in scientific field (Chemistry or Biochemistry preferred)
• Equivalent combination of education and years of related experience may be substituted

EXPERIENCE

• 1+ years of related experience and/or training preferred
• IVD immunoassay manufacturing experience is preferred
• Experience in working with potentially hazardous chemicals and human source materials preferred
• Familiarity with Quality System Regulations and ISO 13485 regulations is a plus

KNOWLEDGE, SKILLS, ABILITIES

• Strong laboratory skills including pipetting, safety, and hazardous chemical handling and knowledge of safety precautions
• Ability to perform tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulations
• Ability to be organized and detail oriented to be able to prioritize own and other’s work and meet business productivity metrics
• Self-sufficient, self-motivated, and focused

PHYSICAL REQUIREMENTS / WORK ENVIRONMENT

• Ability to routinely lift 25 pounds

• Manufacture products including reagents, calibrators, buffers, controls, and intermediates, and complete batch records while maintaining cGMPs and GDP standards
• Perform in-process testing using clinical analyzers, review and analyze data
• Review other manufacturing operators/scientist’s batch records
• Maintain and analyzes lot histories for trends and discrepancies
• Perform laboratory activities including weighing, transferring, and mixing required chemicals and performing product filtration
• Participate in process improvement projects to improve efficiencies and support business needs
• May modify SOPs, work instructions and reports with guidance
• Initiate and support investigations for nonconformances and deviations
• Maintain and troubleshoot equipment as appropriate
• Keep department supervisor and/or manager updated on all issues
• Perform other job duties as required