Senior Group Leader - Extractables & Leachables

Thermo Fisher Scientific•Middleton, WI

29d•Onsite

About The Position

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.

Requirements

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
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
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.

Responsibilities

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.