Associate Director, Bioanalytical Laboratory

MESO SCALE DIAGNOSTICS, LLC.•Gaithersburg, MD

1d•$151,400 - $236,600•Onsite

About The Position

This position is responsible for planning, organizing and directing bioanalytical principal investigator and sample testing resources of a bioanalytical laboratory performing assay validations and sample analysis. The Associate Director, Bioanalytical Laboratory is a subject matter expert in one or more types of assays run on the MSD platform and provides technical guidance for bioanalytical methods developed and used in the laboratory, as well as ensuring laboratory and employee proficiency in these methods. This role also provides input to senior management in developing the group’s overall strategies and business plans.

Requirements

A minimum of 8 years of overall experience in immunoassay development in an industrial environment or bioanalytical sample testing in a GLP/GCLP environment in positions of increasing responsibility is required.
A minimum of 4 years of experience managing biomarker development and/or bioanalytical sample testing projects and directly or indirectly managing associated resources is required.
Training in and experience with GLP/GCLP is required.
Knowledge of laboratory information systems, data review and analysis, quality assurance and management systems.
Broad knowledge of laboratory operations including expertise in immunoassay validation.
Knowledge of GLP/GCLP requirements as applicable to bioanalytical sample testing.
Knowledge of safety aspects of working with biological hazards.
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.
Professional presence and strong interpersonal skills for interacting in a courteous, timely, and diplomatic manner with all levels of employees as well as other parties/stakeholders involved with the company.
Demonstrated critical thinking and analytical skills, as well as the ability to handle complex situations and demonstrate sound judgment and problem solving.
Excellent organizational, planning, and time management skills with the ability to manage multiple and often changing priorities and issues of varying complexity, while meeting time-sensitive deadlines and deliverables.
Solid leadership skills with demonstrated knowledge and understanding of staff management practices and processes and the ability to establish accountabilities and expectations and manage performance to achieve results.
Attention to detail with a demonstrated commitment to excellence and performance improvement and the drive to deliver quality and value-added results and outcomes.
Proficiency in MS Office Suite.

Nice To Haves

Ph.D. in Biology, Chemistry, or related scientific discipline is preferred.
Master’s degree may be substituted with additional relevant experience.

Responsibilities

Responsible for bioanalytical laboratory resources performing assay validations and sample analysis, including compliance with regulatory standards.
Implements and maintains 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.
Ensures that all direct and indirect reports receive the appropriate training for the type and complexity of the services offered; manages associated training plans to ensure training is kept current; and evaluates and addresses training and/or continuous education needs of their staff.
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.
Provides input regarding budgets for laboratory operation, including staffing, operating expenses, materials and capital equipment.
Participates in the human resource management functions including hiring, orientation and training.
Coordinates, along with head of laboratory operations and senior laboratory management, daily operations of the laboratory, including 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.
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.
Promotes a culture of high performance and continuous improvement that values learning and a commitment to quality.
Participates in professional conferences and workshops and presents results of BAL projects.