As a Sr. 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.
(Please note this is a representative summary of responsibilities, not a comprehensive or exclusive list of the duties to be performed in any position. Employees must follow instructions and perform additional duties as requested.)
