Principal Scientist - Method Development & Validation (GMP)

Thermo Fisher Scientific • Middleton, WI

4d • 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. 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.

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.
• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 5,001-10,000 employees