Director, Bioanalytical Laboratory

Bioanalytical Laboratory Manager

This position is responsible for planning, organizing and directing the resources of a bioanalytical laboratory performing assay validations and sample analysis. In collaboration with senior laboratory management, this role is responsible for contributing to the strategy, direction and goal setting for the laboratory and maintaining high quality services through effective management of employees and processes, and through implementation of continuous quality improvements (CQI).

This role is a subject matter expert in all types of assays run within the Bioanalytical Laboratory (BAL) and provides technical guidance for methods developed and used in the laboratory.

Duties and responsibilities include:

• Responsible for operation and of the BAL, including compliance with local, state, and federal regulations and standards.
• Acts as a subject matter expert in all assays run within the BAL, including biomarker, immunogenicity (IG) and pharmacokinetic (PK) assays and provides technical guidance for bioanalytical methods developed and used in the laboratory.
• Establishes laboratory procedures, information systems, documentation and processes compliant with applicable elements of Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP).
• Provides leadership and management to staff consistent with applicable GLP and GCLP requirements.
• Responsible for the implementation, monitoring and evaluation of performance improvement and CQI activities.
• Ensures that all laboratory staff receive the appropriate training for the type and complexity of the services offered; evaluates and addresses overall training and/or continuous education needs and ensures that supervisors manage training plans to ensure training is kept current.
• Ensures all operations are performed in accordance with released SOPs, quality control and safety requirements.
• Ensures laboratory procedures, methods and staff produce high quality services through a combination of observation and data evaluation.
• In collaboration with senior laboratory management, prepares and maintains budgets for laboratory operation, including staffing, operating expenses, materials and capital equipment.
• Participates in the human resource management functions including hiring, orientation and training.
• Establishes and monitors staff performance and development goals, assigns accountabilities, sets objectives, establishes priorities, and provides continuous feedback and recognition on performance. Helps identify high performers to groom for potential succession planning.
• Oversees coordination of daily operations of the laboratory, including but not limited to, testing and staff schedules.
• Represents the organization in a positive and professional manner in meetings with customers.
• Maintains appropriate accessibility to the laboratory at all times.
• Participates in professional conferences and workshops and presents results of BAL projects.

Experience and qualifications required include:

• Ph.D. in Biology, Chemistry, or related scientific discipline is preferred.
• Master's degree may be substituted with additional relevant experience.
• A minimum of 10 years of overall experience in immunoassay development in an industrial environment or bioanalytical sample testing in a GLP/GCLP environment is required.
• A minimum of 6 years of experience leading Biomarker development and/or bioanalytical sample testing projects and directly or indirectly managing associated resources is required.
• A minimum of 4 years of supervisory experience.
• Training in and experience with GLP/GCLP is required.

Knowledge, skills and abilities include:

• Outstanding interpersonal communication skills including presentation and training skills.
• Thorough understanding of the principles of immunoassays, their development and their applicability in different research fields.
• Superior analytical skills and strong scientific fundamentals.
• Expert level knowledge of immunoassays including biomarker, immunogenicity (IG) and pharmacokinetic (PK) assays.
• Knowledge of GLP/GCLP requirements as applicable to bioanalytical sample testing.
• Knowledge of laboratory information systems, budgeting, data…