Director, GMP Labs

Overview

Join Thermo Fisher Scientific as a Director leading GMP Labs in Athlone, Ireland. This pivotal role oversees multiple sites, departments, or regions within global laboratories, integrating operational processes, research and development, quality assurance, and business development to drive peak performance. The Director influences scientific strategy and laboratory testing protocols across various therapeutic areas to support pharmaceutical-sponsored CMC studies.

Key Responsibilities

• Establish and enforce operational goals and laboratory policies while supervising resource allocation such as space, capital equipment, and scientific instruments.
• Assess and fulfill staffing requirements, manage laboratory productivity, ensure appropriate training, and cultivate leadership and talent succession plans for high-performing teams.
• Develop and monitor consistent performance standards, harmonize assays across labs, and act as the main escalation contact for laboratory sponsors.
• Conduct financial analyses to enhance cost-effectiveness, oversee budgets to reduce expenses, report business progress to senior management, and partner with site leadership for lab expansion planning and execution.

Qualifications and Experience

• Equivalent to at least 12 years of relevant education, training, and experience combining to provide required knowledge and skills.
• Minimum of 5 years managerial experience.
• Strong leadership capabilities.

Expertise and Abilities

• Extensive knowledge of pharmaceutical operations, including laboratory analytical science encompassing chemistry, biochemistry, biology, and microbiology.
• Comprehensive understanding of GMP and FDA regulations related to Analytical Development and Quality Control laboratory functions such as method development, method validation, drug release, and stability testing.
• Exceptional communication, interpersonal, and presentation skills.
• Proficient in budgeting, forecasting, strategic planning, and driving results.
• Global and cultural awareness with experience in business mergers, acquisitions, and integration of business units.
• Strong organizational agility along with excellent coaching, mentoring, marketing, and negotiation skills.

Working Environment

• Role involves working in offices, laboratories, and clinical environments with possible exposure to electrical equipment.
• Frequent travel to various sites within the United States and occasional international trips expected.
• Rarely exposed to biological fluids, infectious agents, skin and lung irritants, radiation, toxic substances, and hazardous waste.
• Use of personal protective equipment such as eyewear, protective garments, and gloves is regularly required.
• Occasional exposure to fluctuating or extreme temperatures.

Work Schedule

Standard Monday through Friday schedule.