Senior Scientist - GMP Laboratory

About the role

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 is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. 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.

Responsibilities

The Senior Scientist independently performs complex laboratory testing and provides hands-on technical coaching and mentorship within the laboratory. This role is focused on being an in-lab proven contributor who actively executes, troubleshoots, and improves testing activities while developing in-depth subject matter expertise in assigned methods, assays, or analytical platforms.

• Independently performs complex laboratory testing, including challenging routine testing, analytical investigation support, development, transfer, or validation activities.
• Communicates analytical needs, resources, and/or barriers with relevant stakeholders.
• Maintains a strong hands-on laboratory presence and serves as a technical resource during test execution.
• Actively assists with testing execution, troubleshooting, and optimization rather than directing work from outside the lab.
• Applies advanced scientific judgment to execution strategy, data interpretation, and problem resolution.
• Develops and maintains subject matter expertise in one or more analytical methods, assays, or platform technologies.
• Serves as a technical escalation point for execution level testing issues encountered during routine (release, stability, quality control) or non-routine (development, transfer, validation) work.
• Identifies method, execution, or workflow improvements that enhance data quality and downstream routine testing robustness.
• May independently execute or technically lead defined components of method development, transfer, or validation work.
• Authors and/or reviews non-routine technical deliverables such as methods, protocols, reports, and quality records.
• Supports transition of improved or newly established methods into routine testing by strengthening clarity, robustness, and usability.
• Acts as a key in-lab technical resource for complex or escalated routine testing.
• Assists analysts with execution strategy, atypical results, and troubleshooting for established methods.
• Supports quality management through hands-on data review and root cause analysis.
• Trains, mentors, and equips Scientist I and II staff through direct laboratory involvement and technical coaching.
• Reinforces best practices through example and active participation in testing activities.

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 5+ years’ experience) or equivalent combination of education, training, & experience.
• Previous GMP Laboratory experience strongly preferred
• Previous experience with HPLC, CE, iCE, or ELISA strongly preferred
• Previous experience with cell culture, mammalian cell culture, flow cytometry, PCR, ELISA, or cell-based bioassays strongly preferred
• Previous experience with method troubleshooting, optimization, and/or validation preferred
• Advanced knowledge of analytical testing techniques, laboratory instrumentation, and method execution in a regulated environment.
• Demonstrated ability to independently execute complex testing, investigations, and non-routine laboratory activities.
• Strong troubleshooting, problem-solving, and critical thinking skills, with the ability to identify analytical challenges at the source and implement effective solutions.
• Proven ability to develop and maintain subject matter expertise in assigned methods, assays, or analytical platforms.
• Versed in data analysis with the ability to identify trends, outliers, and atypical results.
• Strong attention to detail and commitment to data integrity, quality, and accuracy.
• Working knowledge of GMP requirements and data integrity principles.
• Excellent organizational skills with the ability to adapt to changing priorities while maintaining focus, composure, and productivity.
• Ability to prioritize and execute multiple assignments with challenging or conflicting deadlines in a dynamic laboratory environment.
• Ability to mentor and technically develop scientific staff through hands-on guidance and knowledge transfer.
• Strong written and verbal communication skills, particularly for technical documentation and scientific discussion.
• Demonstrated ability to work collaboratively, maintain a positive attitude, and contribute effectively within a team environment.
• Demonstrated experience in identifying and resolving conflicts in a professional and constructive manner.
• Ability to maintain a high degree of confidentiality with client information and data.
• Proficiency with Microsoft Office applications (e.g., Word, Excel, Power BI, PowerPoint, Teams, SharePoint).
• Familiarity with data collection and laboratory software used to support analytical testing.

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.

• 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.