Sr. Scientist Mass Spec Production (LC-MSMS)
Kansas City, MO - USA
Job Summary
When you work as a Sr. Scientist in the Mass Spec Bioanalysis Production group at KCAS you get to further our mission by leveraging your knowledge in bioanalytical and scientific principles to be responsible for carrying out all aspects of regulated studies from study setup through reporting. You will also utilize your strong base in scientific principles and regulatory expectations to ensure data integrity troubleshoot issues and deliver high-quality results in a GLP-compliant environment.
Our Mass Spec Bioanalysis Development team uses LC-MS/MS (Liquid ChromatographyTandem Mass Spectrometry) techniques and sophisticated sample preparation methods to meet bioanalytical needs for drug discovery preclinical and clinical studies including the bioanalysis of drugs and metabolites biomarkers and active endogenous compounds in biological fluids and tissues.- Execute and oversee all phases of assigned studies including sample preparation LC-MS/MS analysis data review and report generation in a regulated environment
- Act as lead scientist on studies providing work direction technical guidance and training to junior scientific staff
- Be responsible for all client communication related to study conduct and data delivery
- Interact with QAU to resolve audit findings deviations and compliance-related issues
- Have final authority for sample identification including resolution of discrepancies with clinical sites and/or clients
- Be accountable for study timelines deliverables and communication of status to management and clients
- Ensure compliance of all study activities with study protocols SOPs & GLP regulatory requirements
- Review and ensure accuracy completeness and integrity of data prior to reporting
- Support audit readiness and participate in client and regulatory inspections as needed
- Act as a technical resource for troubleshooting assay performance and operational challenges within a production environment
- Perform all aspects of the job in a way that supports company brand and supports company mission vision and values
- Bachelors Masters or PhD in Chemistry Biochemistry or related field with at least 5 years of experience in a bioanalytical laboratory environment
- Extensive hands-on experience working in a GLP-regulated laboratory environment (required)
- Strong experience with bioanalytical sample preparation and quantitative LC-MS/MS workflows
- Experience executing regulated studies including data review reporting and audit support
- Demonstrated ability to troubleshoot technical and operational issues in a production environment
- Experience interacting with Quality Assurance and supporting audits and inspections
- Prior experience acting as a study lead or Principal Investigatortype role preferred
Required Experience:
Senior IC
About Company
As a full-service bioanalytical CRO and biomarker partner, KCAS Bio helps accelerate drug development in the pharma and biopharma industries with large and small molecule bioanalysis.