ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Perform analysis of highly complex laboratory assays based on protocols and in compliance with SOPs and GLP regulations.
- Review, interpret and integrate data on assigned studies, using the assistance of scientific staff as appropriate.
- Record project data in accordance with GLP regulations to include creation of Laboratory Methods, data package assembly and assisting in the quality control of project work.
- Set up laboratory instrumentation utilizing departmental and instrumental software with minimal supervision.
- Troubleshoot laboratory instrumentation and perform basic maintenance.
- Develop, validate and conduct studies in collaboration with scientific staff in compliance with applicable regulations.
- With guidance, participate in and coordinate phases of the study planning process with appropriate departments.
- Assist in method development and refinement, and validation.
- May provide technical direction and mentoring to less experienced staff.
- Adhere to current health and safety regulations.
- Perform all other related duties as assigned.
- Six to eight years previous directly related laboratory experience in a pharmaceutical or contract laboratory environment.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Exceptional analytical and problem solving capabilities.
- Full understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and Good Laboratory Practices (GLPs), as appropriate.
- Excellent written and verbal communication skills.
- Able to prioritize work and meet deadlines.
- High level of proficiency in the use of standard software including Microsoft Excel, Word, Powerpoint, etc. and with standard laboratory calculations.