Job Description
- Coordinates projects and work activities with Laboratory Management to meet established objectives
- Exhibits good interpersonal skills, a professional attitude, and excellent written and oral communication to produce consistently high-quality work
- Prepare solutions and reagents used in the laboratory and document them in the lab notebook promptly
- Perform tasks assigned by the senior scientist on sample processing, method validation, method development experiments
- Maintain calibration records for laboratory equipment and instruments, keep inventory and expiration for materials, chemical reagents, consumables, samples, and solvents
- Ensure cleanliness, adequate inventory, organization, unambiguous labeling, current calibrations, personal safety, and ensure all reagents for use are not expired or compromised
- Perform study sample analysis and generates analytical test results in compliance with SOPs/protocols using applicable guidelines: GLP (OECD), EMEA, ICH, FDA, and other GxP requirements
- Document and communicate any deviations to these instructions directly to the Principal Investigator (for GLP studies) or Study Director (for Non-GLP studies)
- Assist Senior scientists in literature search, plan and carry out complex research projects, such as new method development of new drugs and testing methods
- Develop and conduct analytical method validation/qualification/ transfer and study sample analysis according to protocol, SOPs, and regulatory guidance (GLP/GCP) and additional regulations as required
- Perform task assigned by the senior scientist on sample processing and method validation experiments
- Perform experiments as per Standard Operating Procedure (SOPs) and as required by study protocols
- Conduct tests on materials and other substances to ensure that safety and quality standards met
- Revise/review/author test methods and technical reports
- Generate method procedures, results, validation, re-validation, and analytical reports for direct submission to regulatory authorities (FDA)
- Support Sponsor audits and reviews compliance with sample management, including central lab services and Environmental Monitoring System-related activities
- Compile and archive study/validation data
- Generate method procedures, results, validation, re-validation, and analytical reports for direct submission to regulatory authorities
- Assist in sample management for long-term storage of biological samples such as plasma, urine, serum, whole blood, CSF, FFPE blocks/ slides of tissue biopsy
Qualifications / Experience
- M.S/B.S in biochemistry, analytical chemistry, life sciences, biotechnology, or related areas
- 3+ years experience in analytical or clinical research setting
- Familiarity with EDC system is an asset
- Proven ability to multitask and prioritize
- Excellent oral and written communication skills
- Ability to work independently with excellent attention to detail
- Excellent organization and problem-solving skills
- Ability to keep detailed and accurate records
- Proficiency with MS Office, Excel, and Word
If interested, please e-mail your resume to careers@nebiolab.com.