Senior Scientist - Biosafety, GMP

Thermo Fisher Scientific•Middleton, WI

1d•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 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. 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. Role Overview: 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. A Senior Scientist may operate either as a non-routine technical contributor for method development, transfer, or validation activities or as a key technical resource for complex or priority routine testing. In all cases, the Senior Scientist remains directly involved in laboratory execution and testing oversight, owns non-routine technical deliverables within defined scope, and mentors Scientist I and II staff to ensure high-quality, consistent laboratory performance. This role serves as a senior technical contributor and escalation resource within the laboratory. The Senior Scientist is responsible for the quality and technical accuracy of assigned deliverables (data, reports, methods, and protocols) but does not own overall program delivery, routine study management, or primary technical client communication. Client interaction may occur for methodspecific technical discussions but does not include ownership of broader client relationships or project coordination. Scientific decisions that impact method lifecycle, validation strategy, or broader testing models are escalated to Staff Scientist + for approval. This role is distinct from a Study Lead and does not own routine study/program management, project coordination, or primary client-facing responsibilities.

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). 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.
Advanced knowledge of analytical testing techniques, laboratory instrumentation, and method execution in a regulated environment.
Hands-on experience with PCR/qPCR, DNA extraction, and working with viral samples or virus-based assays strongly preferred.
Demonstrated ability to independently execute complex testing, investigations, and non-routine laboratory activities.
Experience with analytical method development, qualification, and validation, including designing, optimizing, and validating methods in GMP regulated laboratory strongly preferred.
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, PowerBI, PowerPoint, Teams, SharePoint).
Familiarity with data collection and laboratory software used to support analytical testing.
Demonstrated ability to receive, constructive feedback to continuously improve performance.
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

Nice To Haves

Hands-on experience with PCR/qPCR, DNA extraction, and working with viral samples or virus-based assays strongly preferred.
Experience with analytical method development, qualification, and validation, including designing, optimizing, and validating methods in GMP regulated laboratory strongly preferred.

Responsibilities

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.