Job Description
Title: Clinical Pathology Laboratory Manager/Principal Scientist
Full-time
Position Description:
The Clinical Pathology Laboratory Manager provides operational and technical leadership with scientific insights for the clinical pathology laboratory within Nonclinical Drug Safety Department. The successful candidate will ensure accurate, timely, and compliant delivery of laboratory data, and collaborates with stakeholders across functions to support nonclinical studies and development decisions across the pipeline from early discovery to submissions and post-marketing requirements. This role reports to the head of Clinical Pathology group.
Key Responsibilities:
Operational Leadership
- Manage day-to-day functions of the clinical pathology laboratory, including hematology, coagulation, clinical chemistry, urinalysis, and related areas in multiple nonclinical species (rodents and non-rodents). This role will include instrument operation and data generation on a rotating basis.
- Supervise laboratory personnel: hiring, onboarding, scheduling, performance reviews, and career development.
- Ensure appropriate staffing levels and competency through workforce planning and cross-training.
Quality and Compliance
- Ensure compliance with institutional policies in a regulated environment (Good Laboratory Practice).
- Oversee validation and documentation for new assays, instruments, and software updates.
Technical and Analytical Oversight
- Monitor test performance, instrument functionality, and quality control (QC) metrics; respond to QC failures and implement corrective actions.
- Evaluate new technologies, reagents, and automation opportunities; lead implementation projects as needed.
Safety and Environment
- Promote and enforce a safe work environment, ensuring adherence to biosafety, chemical safety, and waste disposal regulations.
- Ensure staff are appropriately trained in the safety policies and use of personal protective equipment laboratory operations.
Communication and Collaboration
- Serve as the primary point of contact between laboratory and stakeholders.
- Prepare and present reports on laboratory performance, quality metrics, and improvement projects.
- Participate in multidisciplinary committees and contribute to laboratory strategy.
Qualifications:
Required:
- Bachelor's degree in Medical Laboratory Science, Clinical Laboratory Science, Biology, Chemistry, or related field.
- ASCP (MLS/MLT) or equivalent certification required.
- Minimum 10 years of clinical laboratory experience with at least 2 years in a supervisory or lead role in clinical pathology or equivalent sections with recent experience managing day-to-day operations of a clinical pathology laboratory, including hematology, coagulation, clinical chemistry, and urinalysis.
- Strong knowledge of clinical laboratory operations, instrumentation, quality systems, and regulatory requirements (GLP).
- Proven leadership, communication, and team development skills.
- Proficiency with laboratory information systems (LIS) and electronic laboratory notebooks.
Preferred:
- Master’s degree in clinical laboratory science or related field.
- Prior experience in a hospital-based or high-volume clinical laboratory.
Competencies:
- Leadership and people management.
- Decision-making and problem solving.
- Quality and regulatory focus.
- Resource optimization.
- Effective communication.
- Technical aptitude and continuous learning.
Working Conditions:
- Primarily laboratory environment with intermittent exposure to biological specimens, chemical reagents, and laboratory equipment noise.
- Requires use of PPE and adherence to safety protocols.
- On site office and laboratory-based position.
Required Skills:
- Chemical Safety
- Clinical Chemistry
- Clinical Judgment
- Clinical Laboratory Instrumentation
- Clinical Laboratory Management
- Clinical Pathology
- Coagulation
- Collaborative Communications
- Detail-Oriented
- GLP Regulations
- GMP Laboratory
- Hematology
- Improvement Projects
- Innovation
- Intellectual Curiosity
- Laboratory Documentation
- Laboratory Informatics
- Laboratory Information Management System (LIMS)
- Laboratory Information Systems (LIS)
- Medical Laboratories
- Medical Laboratory Sciences
- Microscopic Imaging
- Morphology
- Pathology
