Director, Bioanalytical Laboratory

MSD; Gaithersburg (MD); On-site; USD 174,000 - 272,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with company matching

Paid vacation and holidays

Disability insurance

Job summary

MSD in Gaithersburg, MD seeks an expert to plan, direct, and optimize a BAL with a focus on immunoassay development, biomarker and PK methods. You will guide technical strategies and supervise staff, ensuring GLP/GCLP adherence and CQI-driven improvements.

The role requires a Ph.D. in biology or chemistry (or equivalent), 10+ years in the field, and proven leadership of biomarker projects. Strong training in GLP/GCLP is expected.

Qualifications

• Ph.D. in Biology, Chemistry, or related scientific discipline preferred.
• A minimum of 10 years in immunoassay development in an industrial or GLP/GCLP environment.
• A minimum of 6 years leading Biomarker development and/or bioanalytical projects and managing resources.
• A minimum of 4 years of supervisory experience.
• Training in and experience with GLP/GCLP is required.

Responsibilities

• Oversee BAL operations ensuring GLP/GCLP compliance and safety.
• Act as SME for biomarker, IG, and PK assays; provide technical guidance.
• Establish procedures, documentation, and processes aligned with GLP/GCLP.
• Provide leadership and management to staff per GLP/GCLP requirements.
• Implement, monitor and evaluate CQI activities.
• Ensure staff training and continuous education; manage training plans.
• Oversee daily operations, staffing and scheduling of the laboratory.
• Prepare and monitor budgets for laboratory operation.

Skills

Immunoassay development

Leadership

Communication

Biomarker analysis

Quality systems

GLP/GCLP knowledge

Education

Ph.D. in Biology or Chemistry

Master's degree (relevant)

Tools

MS Office Suite

Laboratory information systems

Job description

POSITION SUMMARY:

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:

• 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:

• 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 i
• Training in and experience with GLP/GCLP is required.

KNOWLEDGE, SKILLS AND ABILITIES:

• 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 review and analysis, quality assurance and management systems.
• Broad knowledge of laboratory operations including expertise in immunoassay validation.
• 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.
• Superior 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.
• Ability to work effectively in a fast-paced, high-energy, demanding and deadline driven environment.
• Expert level knowledge of biomarker, immunogenicity and pharmacokinetic assays.
• Knowledge of safety aspects of working with biological hazards.
• Excellent verbal and written communication/interpersonal skills.
• Proficiency in MS Office Suite.

PHYSICAL DEMANDS:

• This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.
• Limited travel.

WORK ENVIRONMENT:

• This position is performed in a traditional office environment with periodic requirements to work with laboratory personnel in their designated work areas.

COMPENSATION SUMMARY:

The annual base salary for this position ranges from $174,100 to $272,100. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate’s knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.

BENEFITS SUMMARY:

At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.

EEO/AA STATEMENT:

MSD is an Equal Opportunity/Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please click on the following link: https://www.mesoscale.com/en/our_company/careers/equal_employment_opportunity_statement.

Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.