Data Reviewer - Analytical R&D
Thermo Fisher
Summary
Provides review of data collected by the Analytical R&D department. Provides technical assessment of the data and documents. Ensures that all data has been collected in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (GMP) and corporate quality standards. Data will be related to testing and method development/validation for raw materials, production intermediates, and final products on highly unique and complex projects. May be involved in pre-clinical, clinical, and/or post-marketing stages of drug development.
Job description
Essential Functions
Liaises with Analytical R&D scientists to discuss the data, documentation, and analytical documents (methods, protocols, reports). Must have strong technical knowledge of HPLC, GC, KF, FTIR, and NMR. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines. Maintains the necessary compliance status required by company and facility standards. Performs other duties as assigned.
Competencies
- Technical excellence in the understanding and application of analytical chemistry.
- Excellent interpersonal and communication skills.
- Well organized, detail oriented and able to prioritize multiple tasks.
- Experience with Microsoft Word and Excel
- Understanding of Analytical R&D software systems, such as Empower, that are being applied within modern pharmaceutical companies
- Excellent working knowledge of Good Manufacturing Practices
- Proficiency in the English Language.
- Demonstrated commitment to our fundamental principles of Integrity, Respect and Excellence
Requirements
- BS in Chemistry or commensurate experience required
- Requires 10 years of progressive scientific experience in an analytical laboratory environment
- Hands-on experience with HPLC, GC, KF, and FTIR
- Strong technical knowledge of NMR
- Technical excellence in the understanding and application of analytical chemistry
- Excellent interpersonal and communication skills
- Well organized, detail oriented and able to prioritize multiple tasks
- Experience with Microsoft Word and Excel
- Understanding of Analytical R&D software systems, such as Empower
- Excellent working knowledge of Good Manufacturing Practices
- Proficiency in the English Language
Company overview
Thermo Fisher Scientific is a global leader in serving science, with annual revenue of approximately $40 billion. The company provides a comprehensive portfolio of analytical instruments, equipment, reagents and consumables, software, and services for research, analysis, discovery, and diagnostics. Their mission is to enable customers to make the world healthier, cleaner, and safer by accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, and increasing laboratory productivity. Thermo Fisher serves pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions, and government agencies worldwide. The company operates through four business segments: Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products and Services.