As a Senior Scientist at KCAS Bio, you will serve as a lead technical contributor on complex bioanalytical studies, with the ability to independently execute and/or oversee all phases from study setup through final reporting, including method development and validation.
Leveraging a strong foundation in scientific principles, you will evaluate data quality, troubleshoot complex technical challenges, and ensure compliance with applicable regulatory standards.
In this role, you will act as a trusted internal expert, contributing to the advancement of scientific quality and operational efficiency while mentoring and developing less experienced scientific staff.
In this role, we will rely on you to:
- Serve as lead scientist on complex studies, independently designing, executing, and troubleshooting bioanalytical methods and workflows.
- Demonstrated experience as PI on complex or high-visibility programs, including multi-analyte, multi-matrix, or global studies
- Experience supporting regulatory submissions (IND, NDA, BLA) with bioanalytical data as acting PI or key contributor
- Develop, optimize, and validate analytical methods to support drug discovery and development programs.
- Provide advanced troubleshooting support for method performance, instrumentation, and study execution issues.
- Author and review validation protocols, study plans, reports, and investigations in accordance with regulatory and quality standards.
- Provide scientific and technical support for sponsor interactions, contributing data interpretation and study rationale as needed.
- Develop and maintain SOPs and provide guidance on analytical procedures.
- Stay current with evolving scientific methodologies, instrumentation, and industry trends; apply knowledge to improve study quality and operational efficiency.
- Mentor Scientists and junior staff through hands-on training, technical guidance, and knowledge sharing.
- Perform all duties in alignment with company mission, values, and quality expectations.
To qualify specifically for this role, you will have:
- Bachelor’s degree in a scientific discipline (advanced degree preferred).
- 10–12+ years of relevant experience in research, CRO, or pharmaceutical environment.
- Expert knowledge of applicable laboratory techniques and instrumentation.
- Strong understanding of regulatory requirements and quality systems.
- Strong attention to detail and commitment to scientific excellence.
- Effective written and verbal communication skills.
- Strong technical writing and basic computer proficiency.
- Willingness and ability to mentor and coach others.
- Ability to function as a senior individual contributor and scientific role model.
Top Skills
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.
