Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Join us as а Director, GMP Labs to make an Impact at the Forefront of Innovation.

The Director, GMP Labs provides oversight to one or more one or more sites, departments or regions in global Labs. This role involves integrating operational processes, business development, research & development and quality assurance functions for optimal performance within the labs. Additionally, the Director provides leadership in protocol consultation and laboratory testing for multiple therapeutic areas and contributes to the scientific strategy and implementation to support pharmaceutical-sponsored CMC studies.

What You'll Do:
Set operational standards/goals and direct the implementation of laboratory goals and policies. Oversee resource allocation including space, capital equipment and scientific instrumentation.

Identify staffing needs to ensure the laboratory is staffed with qualified personnel. Manage laboratory performance and ensure proper training. Coach people leaders, develop talent succession planning and high performing teams.

Define, implement and monitor standards of performance in functional area . Ensure consistent harmonization of assays across laboratories.

Serve as primary laboratory point of escalation with sponsors.

Perform financial analyses to improve cost efficiency of laboratory operations. Manage and controls budgets for cost expense reduction. Provide business updates to senior leadership. Assist Site leadership in planning and execution of expansion and growth of lab programs.

Education & Experience Requirements:
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years) or equivalent and relevant combination of education, training, & experience.
• 5+ years of management responsibility
• Strong leadership skills
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities:
• Broad knowledge of pharmaceutical operations and product development including laboratory analytical science in chemistry, biochemistry, biology, microbiology .
• In-depth knowledge GMP, FDA regulations concerning Analytical Development and Quality Control lab processes in drug development, method development, method validation, Release and stability testing,
• Excellent communication/interpersonal skills including presentation skills
• In-depth knowledge of budgeting, forecasting management
• Demonstrated strategic planning skills
• In-depth global and cultural awareness
• Knowledgeable in mergers & acquisitions and integrating business units
• Strong organizational agility and demonstrated drive for results
• Excellent coaching and mentoring skills
• Excellent marketing and negotiation skills

Working Conditions and Environment:
• Work is performed in an office and/or laboratory and/or clinic environment with exposure to electrical office equipment.
• Frequently drives to site locations, frequently travels within the United States, occasional international travel.
• Rare exposure to biological fluids with potential exposure to infectious organisms. Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
• Personal protective equipment required in frequently such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Director, GMP Labs - Athlone, Ireland

Job Description