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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 accredited laboratory. Responsibilities include conducting assay validations, sample evaluations, and developing laboratory-specific tests.

The Director of Bioanalytical Immunogenicity is tasked with ensuring optimal laboratory operations while adhering to all applicable regulations and standards at the state, federal, and local levels.

This position emphasizes the importance of delivering high-quality services through effective employee management and the implementation of continuous quality improvement (CQI) initiatives.


DUTIES AND RESPONSIBILITIES:
  • Manage the overall administration and operation of a bioanalytical laboratory, ensuring compliance with regulatory standards.
  • Develop and maintain laboratory procedures and documentation that meet GLP requirements.
  • Lead and guide staff in alignment with cGLP/CLIA standards.
  • Implement, monitor, and assess performance improvement and CQI activities.
  • Ensure all laboratory personnel receive adequate training for the complexity of services provided, maintaining current training plans and addressing educational needs.
  • Guarantee that all operations adhere to established SOPs, quality control, and safety protocols.
  • Conduct regular audits of laboratory areas, processes, and equipment to ensure compliance with safety, quality, and regulatory standards.
  • Ensure high-quality service delivery through systematic observation, data analysis, and proficiency testing.
  • Prepare and manage budgets related to laboratory operations, including personnel, materials, and equipment.
  • Participate in human resource management tasks, including recruitment, onboarding, training, and performance evaluations.
  • Coordinate daily laboratory operations, including testing and personnel scheduling.
  • 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 mandatory.
  • M.S. degree is preferred; relevant experience may substitute for an advanced degree.
  • A minimum of 5 years' experience in leading a GLP laboratory, with at least 2 years in a supervisory role within 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 related to biological hazards.
  • Strong verbal and written communication skills are essential.
  • Demonstrated personnel management skills are required.

PHYSICAL DEMANDS:
  • This position requires sitting for approximately 4-6 hours and walking for about 2 hours daily.
  • Work hours are typically regular but may include evenings or weekends to meet project deadlines.
  • Exposure to biological fluids with potential infectious agents is possible.
  • 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.