Sr. Research Scientist, Bioanalysis
Wilmington, DE US
- Perform small molecule bioanalytical method development, validation and sample analysis in biological matrices using LC-MS/MS based platforms in a regulated environment.
- Provide/present data to pharmacokineticists, toxicokineticists, line management and project teams as needed.
- Compliance with GLP and GCP regulations, follow company policy and SOPs.
- Contribute to Quality Assurance audits through direct interaction with auditors as well as providing resolutions to QA audit findings.
- Draft bioanalytical documents such as validation/sample analysis plans and method validation /sample analysis reports.
- Contribute to maintenance of GLP laboratory through SOP revisions, peer review of bioanalytical data and reports.
- BS/MS or equivalent in analytical chemistry, life sciences or a related discipline with 5 years (BS)/3 years (MS) regulated bioanalysis experience in pharmaceutical companies and/or bioanalytical CROs.
- Strong skills in bioanalytical method development, validation and samples analysis.
- Good knowledge of GLP and GCP regulations and familiarity with the regulatory guidelines on bioanalytical method validation and sample analysis.
- Prior experience with Watson LIMS, Sciex Analyst, and electronic laboratory notebooks (IDBS-ELN) preferred.
- Knowledge of DMPK and overall drug discovery and development process.
- Ability of understanding non-clinical and clinical study protocol is required.
- Excellent organizational, documentation, and communication skills.
- Hands-on experience with LC-MS based large molecule characterization and quantification.
- Collaborative, flexible and well organized.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.