Executive Director, GMP Lab

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Please note this role is fully onsite in Middleton, WI.

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their dedication to accuracy and quality to deliver groundbreaking innovations.

Position Summary: The Executive Director leads a state-of-the-art pharmaceutical laboratory organization, providing strategic direction, leadership, and management to the global GMP business.

The Executive Director will lead the Sales and Operating Plan working in a global, matrixed environment and aligned to the GMP business unit goals and objectives. Responsible for increasing revenue, managing margin, and delivering outstanding quality data that exceeds client satisfaction by on-time delivery and execution. Partners with internal teams ranging from Operations, Supply Chain, Product Management, Finance, Engineering, Information Technology, Human Resources, and Commercial to meet business objectives and metrics. As a key member of the senior leadership team, leads BU STRAP planning, space allocation, capital projects, talent development, and leverages advanced technology to address global business challenges.

Key Responsibilities:

• Provides operational leadership to laboratory services. Integrates operational processes, business development, research & development and quality assurance functions for optimal performance within the labs.
• Drives continuous improvement through PPI business systems and partners.
• Supports Business Development in acquiring new customers and managing relationships. Advises the development of new programs for revenue improvement/cost expense reduction, including post-evaluation of new implementations for effectiveness.
• Performs financial reviews, establishes operating budget and develops forecasts improving operating profit. Provides business updates to senior leadership.
• Sets operational standards/goals and ensures the implementation of laboratory goals and policies. Coordinates prioritization including space, capital equipment, scientific instrumentation and staff.
• Performs administrative responsibilities including HR functions, personnel development, facilities management, writing SOPs and PDs.
• Is responsible for the quality assurance and quality control aspects of the lab to ensure compliance with regulatory standards. Build project and business management bench strength (locally and globally), attracting, engaging, and developing an impactful team.

Qualifications:

Education

• Bachelors’ Degree in Science/Technical/Business required, advanced degree preferred.

• Or, an equivalent and relevant combination of education, training, & experience that provides the knowledge, skills, and abilities to perform the job.

Experience

• 15+ years of leading multi-departmental clinical or analytical laboratories
• Proficiency in analytical, bioanalytical or clinical chemistry platforms and methodologies
• Expert business knowledge with comprehensive understanding of the organization and functional area(s) working with multifaceted audiences including executive/corporate leadership and across a large number of functional areas (product management, R&D, finance, commercial, operations, HR, etc.)
• Advancing leadership of team members across multiple departments, regions, and countries (10+ years)
• Meaningful experience with Lean / Six Sigma experience in an industrial environment is helpful

Knowledge, Skills, Abilities

• Versed in operations for pharmaceutical and biotech industries
• In-depth knowledge of laboratory science, GxP, FDA and European regulations concerning relevant lab processes in drug development, method development, method validation, R&D, sample testing and data processing

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