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About the position
The position at Thermo Fisher Scientific involves performing complex laboratory analysis of pharmaceutical products, utilizing analytical instrumentation, and ensuring adherence to industry standards and protocols. The role requires independent execution of method validations, analytical testing, and project leadership, contributing to the improvement of patient health through scientific expertise and quality assurance.
Responsibilities
- Perform complex laboratory analysis of pharmaceutical products using analytical instrumentation.
- Act as project leader on multiple projects, interacting with clients and reviewing data.
- Write reports and protocols, ensuring scientific conduct and communication of regulatory issues.
- Independently perform method validations, method transfers, and analytical testing of pharmaceutical compounds.
- Design and drive experiments with minimal supervision, preparing study protocols and project status reports.
- Mentor and train laboratory team members, coordinating activities and troubleshooting issues.
- Assist with quality systems and new equipment, designing validation protocols and establishing project timelines.
- Review, interpret, and analyze data for compliance with protocols, methods, and regulatory standards.
- Perform self and peer reviews of data for accuracy before submission to QA.
Requirements
- Bachelor's degree or equivalent in a relevant field.
- 5+ years of relevant experience in laboratory analysis and project management.
- Solid understanding of general chemistry and separation science.
- Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements, and FDA guidance.
- Proficiency in Microsoft Excel and Word for data analysis and reporting.
- Proven problem-solving and troubleshooting abilities.
- Effective oral and written communication skills, including technical writing.
- Strong time management and project management skills.
- Ability to work collaboratively in a team environment.
Nice-to-haves
- Experience with Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
- Familiarity with technical operating systems used in laboratory settings.
Benefits
- Health and wellness support programs.
- Opportunities for professional development and training.
