
Director/Senior Director BioAnalytical Services LCMS
- Lenexa, KS
- Permanent
- Full-time
- Design and build out of laboratory and capabilities for LC-MS/MS bioanalytical services.
- Lead LCMS bioanalytical operations for both small molecule and large molecule (biologic) programs.
- Direct method development, validation, and regulated sample analysis under GLP/GCP/CLIA.
- Build and mentor a high-performing team of scientists and technical staff.
- Oversee implementation of LCMS strategies for complex modalities such as peptides, ADCs, and oligonucleotides.
- Ensure regulatory compliance with FDA, EMA, and ICH guidance.
- Manage departmental resources, project timelines, and instrumentation (e.g., SCIEX, Thermo, Waters, Watson).
- Act as scientific liaison in client meetings, regulatory audits, and cross-functional collaborations.
- Support business development and marketing with technical input for proposals and feasibility assessments.
- Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field; M.S. with extensive experience considered.
- 10+ years of progressive experience in a bioanalytical lab environment, with a strong focus on both small molecule and biologics LCMS and supporting automation.
- Demonstrated leadership in a CRO, pharmaceutical, or biotech setting.
- Hands-on expertise in quantitative LC-MS/MS for both small and large molecules.
- Deep understanding of regulatory expectations for bioanalytical method validation (GLP/GCP and ICH-M10 requirements).
- Excellent communication, project management, and client-facing skills.
- LCMS-based analysis of biotherapeutics including intact protein quantitation, peptide mapping, and oligonucleotide quantitation.
- Familiarity with hybrid LBA-LCMS workflows (e.g., immunocapture-LCMS).
- Experience in supporting PK/PD, toxicokinetic, and immunogenicity studies.
- Lead a strategic function at the forefront of modern bioanalysis.
- Work with diverse modalities and advanced LCMS technologies.
- Competitive compensation and full benefits package.
- Opportunity to shape and grow LCMS capabilities within a dynamic organization.