Senior Research Scientist

About the role

The Senior Research Scientist leads the LC-MS/MS bioanalytical laboratory, ensuring high-quality analytical testing, regulatory compliance, operational excellence, and staff development. This role oversees method development, validation, sample analysis, and laboratory operations supporting preclinical and clinical studies in accordance with GLP, ICH M10, and applicable regulatory guidelines. The manager provides strategic leadership while maintaining efficient laboratory workflows, meeting project timelines, and ensuring data integrity.

Responsibilities

• Laboratory Leadership
  • Manage daily operations of the Bioanalytical LC-MS/MS laboratory.
  • Supervise, mentor, and develop scientists, analysts, supervisors, and laboratory staff.
  • Establish and maintain departmental goals, performance metrics, and staffing plans.
  • Foster a culture of scientific excellence, quality, safety, and continuous improvement.
  • Conduct employee performance evaluations and provide coaching and career development.
• Scientific Oversight
  • Oversee LC-MS/MS method development, optimization, validation, and transfer.
  • Review bioanalytical method documents, validation reports, study data, and final reports.
  • Ensure bioanalytical methods meet regulatory expectations, LBRI internal SOPs, and Sponsor requirements.
  • Provide scientific guidance on troubleshooting complex analytical challenges.
  • Support assay development for small molecules, peptides, metabolites, biomarkers, proteins, and macromolecules.
  • Provide ongoing training for staff members.
• Project Management
  • Coordinate multiple client projects simultaneously.
  • Allocate laboratory resources to meet project timelines and deliverables.
  • Collaborate with study directors and business development to support Sponsor needs.
  • Monitor project progress, budgets, and laboratory productivity.
  • Communicate project status effectively with internal teams and Sponsors.
• Quality & Regulatory Compliance
  • Ensure compliance with ICH M10, GLP/GCP regulations, and the Quality Management System.
  • Support internal, Sponsor, and regulatory audits.
  • Review deviations, CAPAs, change controls, and investigations.
  • Maintain complete documentation and data integrity in compliance with ALCOA+ principles.
• Instrumentation Management
  • Oversee operation and maintenance of LC-MS/MS instrumentation, including Sciex Triple Quad instruments, Waters and Shimadzu LC units.
  • Ensure instrument validation and qualification, calibration, preventive maintenance, and troubleshooting.
  • Coordinate with vendors for service and technical support.
  • Evaluate and recommend new instrumentation and technologies.
• Operational Excellence
  • Monitor laboratory key performance indicators including turnaround time, sample throughput, and instrument utilization.
  • Manage laboratory inventory, budgets, and capital equipment planning.
  • Ensure laboratory safety and compliance with environmental health and safety regulations.
  • Represent LBRI at scientific discussions both virtually and in person.
  • Foster a collaborative environment with vendors for new product training and cross-training across internal LBRI teams.
• Sponsor Relations
  • Serve as a scientific point of contact for Sponsors.
  • Participate in Sponsor meetings, audits, and technical discussions.
  • Support proposal development and technical feasibility assessments.
  • Build and maintain strong Sponsor relationships through scientific expertise and reliable project execution.

Requirements

• Ph.D. in Bioanalytical Chemistry with ten (10) years of directly related research experience; or an equivalent combination of education, training, and/or experience.
• Minimum of 2 years of previous personnel supervision.
• Experience as a Bioanalytical leader with deep expertise in LC-MS/MS, method development, method validation, and sample analysis.
• Ability to summarize data and write reports.
• Experience with multiple compound classes amenable for quantification by triple quad LC-MS/MS.
• Knowledge of Good Laboratory Practice Guidelines (FDA, OECD, EPA).
• Preference for experience in a regulated setting (FDA, GLP, ICH, etc.), with ABSciex hardware/software, or bioanalytical sample workflows.
• Demonstrated ability to handle fundamental scientific tasks, with published and/or presented original research in prior roles.
• Superior professional-level written and verbal communication skills.
• High degree of professionalism and excellent problem-solving skills.
• Ability to manage a wide variety of complex tasks and projects simultaneously while meeting multiple deadlines.
• Ability to work independently and as part of a team, and maintain confidential information.
• Professional-level computer skills and advanced experience with Excel.
• Ability to learn department-specific computer systems as needed.
• Must be a U.S. Citizen or permanent resident to gain and maintain access to Kirtland Air Force Base (KAFB).
• Ability to obtain and maintain Select Agent clearance is required.
• This position may require vaccinations/immunizations and involves work inside the ABSL3 facility.
• Post-offer physical and background check are required.

Skills

• Expert knowledge of LC-MS/MS instrumentation, especially QqQ and HRMS.
• Sample preparation techniques.
• Method validation and bioanalytical assays.
• Pharmacokinetics and toxicokinetics.
• Strong understanding of bioanalytical regulatory requirements.
• Familiarity with statistical analysis and data review.
• Strong people management and mentoring skills.
• Excellent organizational and project management abilities.
• Effective written and verbal communication.
• Strategic thinking and problem-solving.

Physical Requirements

Work is performed in an office environment. Will operate standard office equipment and will frequently stand, walk, sit, perform desk-based computer tasks, use a telephone, perform repetitive motions, and occasionally lift objects that weigh up to 10 pounds. The Institute will provide reasonable accommodation to any employee with a disability who requires an accommodation to perform the essential functions of the position.