Summary | Elements of Position: The Laboratory Director is responsible for the overall operation, leadership, direction and administration of the R&D Laboratory to assure appropriate staffing, compliant laboratory controls, and timely output of data. In concert with other departments, develops and implements scientific strategies regarding product quality as well as evaluates the risks associated with these strategies. Anticipates analytical issues early in the R&D development process and provides long range planning for method development and improvements for material testing. Provide scientific expertise on establishing specifications and interface with other Departments to response FDA's requests on drug products. Monitor and assess impact of changes in drug regulations, FDA Guidance and Standards related to analytical requirements in drug submissions.

Impact of Position: | The Laboratory Director reports directly to the Vice President, Regulatory Affairs. Provides key scientific strategies and recommendations to the Upper Management and makes major decisions to assure compliance with cGMP and product quality. The development or modification of analytical procedures to support product submissions and determines the analytical parameters of the drug product as well as establishes the critical parameters needed to manage the life-cycle of the drug product. The experience, skill and knowledge of the Laboratory Director are essential in minimizing product approval delays and assuring the company's ability to compete in the marketplace.

Essential Job Functions: | This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks. 

• Carries out managerial responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.


• Oversees, directs, coordinates and prioritizes the daily activities of the R&D Laboratory and assigned staff


• Responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately, proficiently and for assuring compliance with the applicable regulation.


• Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance.


• Ensure that the physical environment conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical and biological hazards


• Ensure that the test methodologies selected have the capability of providing the quality of results required for patient care; verification procedures used are adequate to determine the accuracy, precision and other pertinent performance characteristics of the method; and laboratory personnel are performing the test methods as required for accurate and reliable results.


• Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system.


• Ensure that reports of test results include pertinent information required for interpretation.


• Establish operations standards for cost control, waste reduction, quality, safety, and complete on-time delivery.


• Establishes group goals and objectives in line with company goals and assures such goals and objectives are met within resource and budget allocations. Establishes department budget and adjusts resources to stay within the approved budget


• Oversee the development of the organization's plans and programs in evaluation of long-range planning and regulatory action on operational performance. Foster a unified culture and promotes a process for collaboration, cooperation, sharing of information and mutual teamwork.


• Establish and maintain lines of communication with internal and external customers in order to ensure a timely response to new analytical service trends and program planning.


• Advise, negotiate, manage and administer all contracts into which the laboratory may enter.


• Lead and direct the development, communication and implementation of effective growth strategies and processes.


• Oversees, participates and approves the interviewing, hiring, of departmental employees; conducts performance evaluations for direct reports; and assists direct report managers with performance evaluation process for their units.


• Provides support, direction and coaching to subordinate employees in the areas of hiring, training, disciplinary action, problem resolution, planning, and work delegation.

Required Knowledge and Skills

• Expert in analytical procedures in pharmaceutical industry. Ability to review and critically evaluate pharmaceutical, analytical/clinical reports, common scientific and technical journals and legal documents. Ability to respond to inquiries from regulatory agencies, other departments or members of the business community.


• In depth understanding of FDA procedures, regulatory trends, cGMP standards, FDA and ICH guidance, and pertinent Federal and local laws related to pharmaceutical regulatory affairs.


• Mathematical and statistical computation methods and techniques.


• Principles and practices of budget preparation and administration


• Working knowledge of the pharmaceutical industry and the drug development process including clinical testing and analytical laboratory practices.


• Established track record of successfully managing an analytical laboratory.


• Supervision and training practices and methods.


• Business, scientific and personal computer software applications, e.g MS Word, Excel, Access, etc.


• Business English usage such as, spelling, grammar and punctuation.


• Principles and practices of budget preparation and administration.


• Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods.


• Create, plan and implement department goals, objectives and practices for effective, efficient and cost effective management of allocated resources. Prepare and present budget/resource requirements.


• Effective communication skills and decision making ability. Able to successfully present information and interpret data to executive management. Ability to build relationships to foster successful collaboration and contribute to team activities.


• Deal with sensitive management and company issues successfully


• Manage multiple projects, duties and assignments.


• Ability to define problems collects data, establish facts and draw valid conclusions. Ability to interpret extensive variety of technical instructions and deal with several abstract and concrete variables. Compile information in order to develop a strategic action plan by applying critical thinking and risk management to develop sound plans of action.


• Directing, coordinating, delegating assignments and reviewing the work of assigned department personnel


• Lead, mentor and influence others in a diverse environment.

Education and Experience | PhD degree in Life Science from an accredited university and seven (7) to ten (10) years pharmaceutical laboratory work experience with minimum 5 of those years in management positions, or equivalent combination of education and experience. 

Physical Requirements and Working Conditions | Incumbents are subject to extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some business (international) travel. Work is performed in a laboratory and office environment.