Description

The Senior Research Scientist is responsible for leading 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 time-lines, and ensuring data integrity.

Key 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, protein and macro-molecules.
Provide on-going training for staff members.

Project Management

Coordinate multiple client projects simultaneously.
Allocate laboratory resources to meet project time-lines 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: 
       o    ICH M10

       o    GLP/GCP regulations 

       o    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:
       o    Turnaround time 

       o    Sample throughput 

       o    Instrument utilization 

       o    Quality metrics 

Manage laboratory inventory, budgets, and capital equipment planning.
Ensure laboratory safety and compliance with environmental health and safety regulations.
Represent LBRI at scientific discussion 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.

Technical Skills

Expert knowledge of: 
       o    LC-MS/MS instrumentation, especially QqQ and HRMS.

       o    Sample preparation techniques 

       o    Method validation 

       o    Bioanalytical assays 

       o    Pharmacokinetics and Toxicokinetic 

Strong understanding of bioanalytical regulatory requirements.
Familiarity with statistical analysis and data review.

Leadership Competencies

Strong people management and mentoring skills. 
Excellent organizational and project management abilities.
Effective written and verbal communication. 
Strategic thinking and problem-solving. 

Requirements

Requires a Ph.D. in Bioanalytical Chemistry as well as ten (10) years of directly related research experience; or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.  Requires a minimum of 2 years of previous personnel supervision.

Must have experience as a Bioanalytical leader with deep expertise in LC-MS/MS, method development, method validation and sample analysis as well as the ability to summarize data and write reports. The ideal candidate should have previous experience with multiple compound classes that are amenable for quantification by triple quad LC-MS/MS.  Must have knowledge of Good Laboratory Practice Guidelines (FDA, OECD, EPA).  Preference will be giving to individuals who have experience in a regulated setting (FDA, GLP, ICH, etc.), with ABSciex hardware/software and / or individuals with experience in bioanalytical sample workflows.  Preference will be given to candidates with direct relevant experience in GLP bioanalytical chemistry.

Must have demonstrated ability to handle fundamental scientific tasks and have published and/or presented original research in prior roles. Requires research experience in a specific discipline. 

Must have superior professional-level written and verbal communication skills; a high degree of professionalism and excellent problem-solving skills.  Demonstrated ability in managing a wide variety of complex tasks and projects simultaneously while meeting multiple deadlines is required.  Must have the ability to work independently and as a part of a team as well as the ability to maintain confidential information.  Requires professional-level computer skills and advanced experience with Excel, as well as the ability to learn department-specific computer systems as needed. 

This position will involve work inside the ABSL3 facility which will require vaccinations/immunizations. Ability to obtain and maintain Select Agent clearance is required. A Post-offer physical and background check are required.  

This position may require vaccinations/immunizations.  A Post-offer physical and background check are required.

 Must be a US Citizen or permanent resident in order to gain and maintain access to Kirtland Air Force base (KAFB).