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 Chromatography–Tandem 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.In this role, we will rely on you to:
- 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
To qualify specifically for this role, you will have:
- Bachelor’s, Master’s, 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 Investigator–type role preferred
Skills Required
- Bachelor’s, Master’s, or PhD in Chemistry, Biochemistry, or a related field
- At least 5 years of experience in a bioanalytical laboratory environment
- Extensive hands-on experience in a GLP-regulated laboratory environment
- 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 Investigator-type role
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What We Do
With its presence in three locations across North America and Europe, KCAS Bio is a leading contract research organization (CRO) employing top scientific talent and providing comprehensive bioanalytical services to the global biopharmaceutical industry from early discovery support through product registration and beyond. The collaboration of the three entities allows for global support in bioanalytical, biomarker, immunogenicity, cellular and molecular assay services along with clinical kitting and sample management. The KCAS family of companies operates in state-of-the-art facilities in the United States and Europe. This business structure enables the expertise, capacity, and flexibility to support the development of all types of drugs, biologics, cell and gene therapies to improve health worldwide. Our purpose is to help accelerate the discovery and development of life-changing drugs smoothly, safely and sustainably.
