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Head of Bioanalytical Immunogenicity

2 months ago

Rockville, Maryland, United States Excelsior Executive Search Full time
POSITION SUMMARY:

This role entails overseeing the strategic planning, organization, and management of a GLP/CLIA certified laboratory, focusing on assay validations, sample evaluations, and the development of laboratory tests.

The Bioanalytical Laboratory Director is tasked with ensuring optimal laboratory operations while adhering to all relevant state, federal, and local regulations and standards. This position emphasizes the delivery of high-quality services through effective employee management and the application of continuous quality improvement (CQI) methodologies.


DUTIES AND RESPONSIBILITIES:
  • Oversee the comprehensive operation and administration of a bioanalytical laboratory, ensuring compliance with regulatory standards.
  • Develop and implement laboratory procedures, documentation, and processes that meet GLP requirements.
  • Maintain laboratory accreditation and certification, including CLIA, while providing leadership aligned with cGLP/CLIA standards.
  • Implement, monitor, and assess performance improvement initiatives and CQI activities.
  • Ensure all laboratory personnel receive adequate training tailored to the complexity of services provided, managing training plans to keep skills current.
  • Conduct routine audits of laboratory processes and equipment to ensure adherence to safety, quality, and regulatory standards.
  • Guarantee that laboratory methods and personnel deliver high-quality services through systematic observation and proficiency testing.
  • Prepare and manage budgets for laboratory operations, encompassing personnel, operational costs, materials, and capital equipment.
  • Engage in human resource management activities, including recruitment, onboarding, training, and performance evaluations of laboratory staff.
  • Coordinate daily laboratory operations, including testing and personnel scheduling, in collaboration with the laboratory manager.
  • Represent the organization professionally in interactions with clients and stakeholders.
  • Maintain consistent accessibility to the laboratory.
  • Oversee the validation program for laboratory-developed tests, ensuring acceptable analytical performance levels.

EXPERIENCE AND QUALIFICATIONS:
  • B.S. degree in chemical, physical, biological, or clinical laboratory science is required.
  • M.S. degree is preferred; relevant experience may substitute for advanced education.
  • A minimum of 5 years' experience in a leadership role within a GLP laboratory, with at least 2 years in a supervisory capacity in a high-complexity clinical laboratory. Experience in establishing high-complexity labs is advantageous.
  • Current CAP certification is preferred.

KNOWLEDGE, SKILLS AND ABILITIES:
  • Familiarity with laboratory accreditation standards, laboratory information systems, budgeting, data analysis, and quality management systems.
  • Comprehensive understanding of laboratory operations, particularly in immunoassay validation and laboratory-developed tests.
  • Awareness of safety protocols when handling biological hazards.
  • Exceptional verbal and written communication skills are essential.
  • Demonstrated personnel management skills are required.

PHYSICAL DEMANDS:
  • This position involves sitting for approximately 4-6 hours daily and walking for about 2 hours.
  • Work is primarily conducted during standard hours but may require occasional evening or weekend hours to meet operational needs.
  • Exposure to biological fluids with potential infectious agents is expected.
  • Personal protective equipment, including lab coats, safety glasses, and gloves, is frequently utilized.
  • Limited travel may be necessary.

WORK ENVIRONMENT:

The work environment includes both office and laboratory settings.