Principal Scientist – Method Development & Validation (GMP) Full-time

Principal Scientist

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.

As a Principal Scientist you will onboard and provide technical oversight of complex method development and validation programs, ensuring scientific rigor, regulatory alignment, and successful execution. Acting as a subject matter expert and technical project leader, you will collaborate cross-functionally to drive program delivery, resolve complex technical challenges, and ensure alignment with client expectations.

You will play a critical role in maintaining and advancing GMP compliance, providing leadership and guidance on regulatory requirements, data integrity, and quality standards. This includes reviewing and evaluating data, authoring and approving protocols and reports, and supporting inspection readiness. Additionally, you will contribute to continuous improvement initiatives and the evaluation and implementation of new technologies to enhance laboratory capabilities and support business growth.

What You'll Do:

• Provides assistance in the evaluation and implementation of new technologies or techniques to help move the business forward.
• Implements effective improvements in systems, processes and procedures increasing productivity, quality and technical expertise in the laboratory.
• Participates in external industry organizations, including delivery of poster and podium presentations at conferences, or publishing in scientific journals.
• Shares subject matter expertise with colleagues at internal PPD training events.
• Serves as a technical resource for PPD management in the assessment of client audit recommendations and SOP review.
• Serves as subject matter expert in discussions with clients and internal PPD staff to resolve scientific issues, study design and project technical requirements.
• Leads project teams conducting complex analytical studies, providing technical project management including study planning, coordination of resources, data evaluation, and client communication.

Education and Experience 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 12+ 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.

Knowledge, Skills, Abilities:

• Proven experience serving as the technical lead on MDV projects in a GMP-regulated environment strongly preferred.
• In-depth technical and industry knowledge in positions of technical leadership, and highly respected among peers for technical expertise.
• Communication / organization skills necessary to drive the implementation of technological innovation for an area or department.
• Active participant in industry discussion groups / technology conferences and presenting at industry events and conferences.
• Knowledge of regulatory agency audits from a technological standpoint and perspective.
• Proven ability to implement process improvement and technological advancement at the group or department level.

Work Environment:

• 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.)
• 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.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

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 to help us deliver tomorrow's breakthroughs!

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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