Principal Investigator / Study Lead – LC-MS Bioanalysis
Columbia, Missouri (On-Site)
Relocation Assistance Available
We are seeking an experienced Principal Investigator / Study Lead – LC-MS Bioanalysis to join a growing bioanalytical team in Columbia, Missouri. This is a senior-level scientific leadership role within a GLP-regulated CRO environment, combining hands-on LC-MS expertise with study leadership, regulatory oversight, and direct client interaction.
This position is not simply a bench scientist role. The individual in this position will function as a scientific lead and Principal Investigator responsible for the oversight, execution, interpretation, and communication of regulated bioanalytical studies. The ideal candidate will understand the expectations of operating within a CRO environment where scientific rigor, regulatory compliance, timelines, and client communication are equally important.
We are specifically seeking candidates with prior PI, Study Lead, Study Director, or equivalent scientific oversight experience within regulated bioanalytical programs.
Key Responsibilities
- Serve as Principal Investigator / Study Lead for GLP-regulated bioanalytical studies
- Provide scientific oversight for studies from initiation through final reporting and client delivery
- Lead bioanalytical method development, validation, troubleshooting, and sample analysis activities using LC-MS/MS platforms
- Review, interpret, approve, and defend scientific data generated under GLP standards
- Act as the primary scientific contact for sponsors and external clients throughout the lifecycle of studies
- Participate in client meetings, study updates, scientific discussions, issue resolution, and data presentations
- Ensure studies are executed in compliance with GLP, SOPs, regulatory expectations, and data integrity standards
- Support audits, inspections, deviations, investigations, CAPAs, and regulatory readiness activities
- Author, review, and approve technical reports, study documentation, protocols, and scientific summaries
- Mentor junior scientists and provide technical leadership across projects
- Drive scientific quality, operational efficiency, and continuous improvement initiatives
- Support instrumentation oversight including maintenance, troubleshooting, calibration, and optimization of Shimadzu, SCIEX, or comparable LC-MS systems
- Collaborate closely with Quality, Regulatory, Operations, and scientific teams to ensure successful study execution and client satisfaction
Required Qualifications
- Bachelor’s degree or higher in Chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or related scientific discipline
- Minimum 5+ years of hands-on LC-MS bioanalytical experience required; significantly more experience preferred for Principal-level consideration
- Direct experience functioning as a Principal Investigator, Study Lead, Study Director, or equivalent scientific lead within regulated studies is strongly preferred
- Extensive GLP experience is required
- Strong understanding of regulated bioanalytical method development, validation, sample analysis, reporting, and data review
- Demonstrated experience interacting directly with external clients/sponsors in a scientific leadership capacity
- Strong understanding of regulatory expectations, documentation practices, data integrity, and compliance requirements
- Ability to independently manage multiple studies, timelines, and priorities within a fast-paced CRO environment
- Excellent technical communication, presentation, and scientific writing skills
Critical Background Requirements
Recent and relevant CRO experience is highly preferred for this position.
Candidates from biotech or pharmaceutical companies may also be considered if they have operated within regulated bioanalytical environments and have held responsibilities involving:
- GLP oversight
- Study leadership
- Regulatory documentation
- Client or sponsor interaction
- Cross-functional scientific coordination
Please note:
Purely academic research backgrounds will generally not translate successfully into this role unless the candidate has direct experience:
- Operating within a GLP-regulated laboratory
- Managing externally sponsored or regulated studies
- Acting in a PI or study leadership capacity
- Interacting directly with outside clients, sponsors, or regulatory stakeholders
- Supporting regulated analytical workflows beyond exploratory/basic academic research
Preferred Experience
- CRO bioanalytical laboratory experience
- PI / Study Director experience within regulated studies
- Client-facing scientific leadership experience
- Experience mentoring or leading scientific teams
- Experience with Shimadzu, SCIEX, Watson, or related systems
- Experience supporting regulatory submissions and audited programs
Additional Insight
This is a highly autonomous scientific leadership role within a growing team environment. The right candidate will be comfortable balancing hands-on technical work with study ownership, regulatory accountability, and client interaction.
Success in this role requires strong scientific judgment, operational maturity, regulatory discipline, and the ability to function as a trusted scientific lead for both internal teams and external sponsors.
If interested and qualified, please apply directly or reach out to [email protected]. Referrals are also appreciated.