Director – Immunogenicity
POSITION SUMMARY:
This position is responsible for planning, organizing and directing the overall operation of a GLP/CLIA laboratory, performing assay validations, sample analysis, and laboratory developed tests. This includes maintaining efficient and effective laboratory operations in compliance with all state, federal and local regulations and standards. The Bioanalytical Laboratory Director is responsible for maintaining high quality services through effective management of employees and processes, and through implementation of continuous quality improvements (CQI). The Bioanalytical Laboratory Director provides technical guidance for bioanalytical methods developed and used in the laboratory, and ensures laboratory and employee proficiency in these methods.
DUTIES AND RESPONSIBILITIES:
- Responsible for overall operation and administration of a bioanalytical laboratory, including compliance with regulatory standards.
- Establishes laboratory procedures, documentation and processes compliant with GLP.
- Establishes and maintains laboratory accreditation and certification, including CLIA.
- Provides leadership and management to staff consistent with cGLP/CLIA requirements.
- Responsible for the implementation, monitoring and evaluation of performance improvement and CQI activities.
- Ensures that all lab personnel receive the appropriate training for the type and complexity of the services offered; manages training plans to ensure training is kept current; and evaluates and addresses training and/or continuous education needs of laboratory personnel.
- Ensures all operations are performed in accordance with released SOPs, quality control and safety requirements.
- Performs routine audits of the laboratory work areas, processes and equipment for compliance to safety, quality, and regulatory requirements.
- Ensures laboratory procedures, methods and personnel produce high quality services through a combination of observation, data evaluation and a proficiency testing program.
- Prepares and maintains budgets for laboratory operation, including personnel, operating expenses, materials and capital equipment.
- Participates in the human resource management functions including hiring, orientation and training, and performance evaluations of laboratory personnel.
- Coordinates, along with laboratory manager, daily operations of the laboratory, including testing and personnel schedules.
- Represents the organization in a positive and professional manner in meetings with customers.
- Maintains appropriate accessibility to the laboratory at all times.
- Oversees validation program for laboratory developed tests, and establishes and maintains acceptable levels of analytical performance for each test.
EXPERIENCE AND QUALIFICATIONS:
- B.S. degree in chemical, physical, biological or clinical laboratory science is required.
- M.S. degree is preferred; additional experience may be substituted for advanced degree.
- A minimum of 5 years’ experience leading a GLP laboratory. A minimum of 2 years’ supervisory experience required in a high complexity clinical laboratory. Experience in establishing high complexity labs is preferred, including CLIA application processing and policies/procedures development.
- Current CAP certification preferred.
KNOWLEDGE, SKILLS AND ABILITIES:
- Knowledge of laboratory accreditation standards, laboratory information systems, budgeting, data review and analysis, quality assurance and management systems.
- Broad knowledge of laboratory operations including expertise in immunoassay validation and laboratory developed tests.
- Knowledge of safety aspects of working with biological hazards.
- Excellent verbal and written communication/interpersonal skills required.
- Proven personnel management capabilities required.
PHYSICAL DEMANDS:
- Position requires sitting for approximately 4-6 hours per day and walking for 2 hours per day.
- Work is performed during regular work hours, but may require evening and/or weekend hours to meet deadlines.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Personal protective equipment worn frequently (lab coat, safety glasses, and gloves).
- Limited travel.
WORK ENVIRONMENT:
- Work is performed in an office and/or laboratory.
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