Senior Group Leader - Extractables & Leachables

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions, Will work with hazardous/toxic materials

Job Description

This is a fully onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. Please note that relocation assistance will be provided for this position.

Must be legally authorized to work in the United States. 

Must be able to pass a comprehensive background check, which includes a drug screening. 

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 experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

As a Senior Group Leader within Extractables/Leachables, you will provide high-level leadership, overseeing a team of experienced scientific leaders specializing in extractables and leachables studies. This role serves as a key integrator across scientific, operational, and commercial functions, combining expertise in analytic techniques, client engagement, operational execution, and strategic initiatives to ensure scope integrity, capacity alignment, quality excellence, and departmental stability in this critical area of analytical services.

What You’ll Do:

Scientific & Client Leadership

• Participate in pre-contract scientific discussions to validate scope, timelines, and technical feasibility of extractables/leachables studies.
• Partner with Business Manager on opportunity assessment and proposal strategy.
• Support project definition and timeline/budget negotiations for complex extractables and leachables programs.
• Serve as escalation point for project risks, client relationships, and challenging scientific issues.

Operational & Resource Oversight

• Align cross-functional resource allocation with project demand and capacity constraints.
• Monitor quality, productivity, timelines, and financial performance metrics specific to extractables/leachables studies.
• Review and approve investigations, deviations, and audit responses.

Leadership of Senior Scientific Team

• Lead and develop a team of senior scientific thought leaders.
• Coach, mentor, and provide performance management to enhance team expertise in applicable methodologies and regulations.
• Drive alignment to departmental goals and succession planning within the department.

Strategic Initiative Execution

• Drive long-term initiatives that enhance efficiency, scalability, and scientific excellence in extractables/leachables testing.
• Define and monitor department performance metrics for quality and productivity.
• Lead SOP review, governance, and quality system enhancements for extractables/leachables processes.

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent.
• 2+ years of direct management responsibility

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 and Abilities:

• Demonstrated experience leading senior scientific professionals
• Strong knowledge of regulatory guidelines (FDA, EMA, ICH)
• Strong financial, project management, and operational acumen
• Excellent executive-level communication skills, with ability to explain complex concepts to diverse audiences

• Demonstrates behaviors which align to the 4i Values of Thermo Fisher
• Cultivates a collaborative work environment with team and across business areas
• Effective written, oral, and presentation communication skills
• Strong stakeholder management skills
• Drives positive change management
• Proven problem solving and troubleshooting abilities
• Understands basic financial terms and definitions as they apply to the business
• Independently develops project proposals/plans
• Strong project and time management skills
• Proven ability to identify and implement common efficiencies across multiple programs/projects
• Demonstrated understanding of the bid process and can utilize expertise of others to develop programs to meet unique client needs
• Proven ability to cope with a dynamic work environment

Work Environment:

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

• Able to work upright and stationary and/or standing for typical working hours.

• Able to lift and move objects up to 25 pounds.

• Able to work in non-traditional work environments.

• Able to use and learn standard office equipment and technology with proficiency.

• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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