This role oversees the overall running of an RUO/GLP bioanalytical sample testing laboratory, including assay validations and sample analysis. This includes keeping laboratory operations efficient and effective while adhering to all state, federal, and municipal regulations, and requirements. The individual is responsible for ensuring high quality services by managing staff and procedures effectively and implementing ongoing quality improvements (CQI). The Bioanalytical Laboratory Director II is an immunogenicity and pharmacokinetic (IG/PK) assay subject matter expert who provides technical direction for bioanalytical methods created and employed in the laboratory, as well as maintaining laboratory and employee proficiency in these procedures.
DUTIES AND RESPONSIBILITIES:
- In charge of the general operation and administration of a bioanalytical laboratory, including regulatory compliance.
- Establishes GLP-compliant laboratory procedures, information systems, documentation, and processes.
- Leads and manages staff in accordance with GLP and related cGLP regulations.
- In charge of implementing, monitoring, and evaluating performance improvement and CQI initiatives.
- Ensures that all laboratory workers receive the proper training for the type and complexity of services provided; oversees training programs to ensure that training is kept current; and assesses and addresses laboratory personnel's training and/or continuing education needs.
- Ensures that all activities are carried out in compliance with published SOPs, quality control, and safety standards.
- Conducts routine audits of laboratory work areas, processes, and equipment to ensure compliance with safety, quality, and regulatory standards.
- Ensures that all activities are carried out in accordance with published SOPs, quality control, and safety standards.
- Routinely audits laboratory work environments, processes, and equipment to ensure compliance with safety, quality, and regulatory standards.
- Observation and data analysis are used to ensure that laboratory procedures, methods, and people provide high-quality services.
- Prepares and maintains laboratory budgets, which include staff, operating expenses, materials, and capital equipment.
- Participates in human resource management activities such as hiring, orientation and training of laboratory workers, and performance reviews.
- Coordinates daily laboratory operations, including tests and personnel schedules, with the laboratory manager.
- In customer encounters, represents the organization in a favorable and professional manner.
- At all times, maintains appropriate access to the laboratory.
EXPERIENCE AND QUALIFICATIONS:
- A PhD. in chemistry, physics, biology, or clinical laboratory science is necessary.
- A minimum of 5 years of experience as the leader of a GLP laboratory is necessary.
- At least 7 years of experience working in a high throughput bioanalytical sample testing environment is necessary.
KNOWLEDGE, SKILLS AND ABILITIES:
- Understanding of laboratory information systems, budgeting, data evaluation and analysis, quality assurance, and management systems is required.
- Broad knowledge of laboratory operations, including immunoassay validation skills.
- Expertise in immunogenicity and pharmacokinetic assays.
- Experience with cGLP regulations as they apply to bioanalytical sample testing is preferred.
- Understanding of the safety implications of working with biological risks.
- Excellent verbal and written communication abilities, as well as interpersonal skills, are necessary.
- Proven personnel management skills are essential.
- This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.
- Limited travel.
- This position is performed in a traditional office environment with periodic requirements to work with laboratory personnel in their designated work areas.