Senior Research Scientist - Technical Project Manager (GMP)

Thermo Fisher Scientific•Middleton, WI

1d•Onsite

About The Position

Position: Senior Research Scientist - Technical Project Manager Location: Middleton, Wisconsin Department: Biopharmaceutical 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. Discover Impactful Work: As a Senior Research Scientist, you will serve as a technical program lead supporting complex client programs within a GMP laboratory environment. This role has both routine and non-routine impact, providing scientific oversight across multiple programs while leading technical aspects of client onboarding, complex investigations, and program execution. You will interact directly with clients to deliver technical updates and recommendations, review data and documentation, and act as a key technical resource for project teams. Additionally, you will mentor junior scientific and project staff, helping to build technical capability and ensure consistent, high-quality execution across programs.

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 10+ 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 ability to troubleshoot complex analytical or technical issues in a GMP environment strongly preferred
Experience mentoring or training junior staff
Excellent written and verbal communication skills, including the ability to engage directly with clients.
Knowledge and application of industry best practices not yet represented by global regulatory requirements
Full theoretical and hands-on understanding and knowledge of general chemistry and separation science
Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations
Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA mentorship
Ability to independently review and understand project proposals/plans
Proven track record in technical writing skills
Ability to work in a collaborative work environment with a team
Ability to independently optimize analytical methods
Time management and project management skills

Responsibilities

Independently plans and guides the scientific approach for analytical methods, method transfers, and specialty technology studies, ensuring alignment with client requirements, program phase, and GMP expectations.
Acts as an on-site Subject Matter Expert (SME) for assigned instrumentation, analytical techniques, or technology platforms, providing scientific guidance to project teams and supporting issue resolution.
Mentor and train junior scientists and TPMs, supporting development of technical understanding, scientific decision-making, and confidence in client interactions.
Evaluates available technical options to acquire desired quality of analytical results, economics, ease of introduction into a production environment, and adaptability in analytical applications.
Demonstrates viability of in-house developed methods and methods transferred from clients by crafting appropriate validation experiments or other appropriate aspects of specialty methodology or technology.
Lead client discussions regarding project definitions, technical information exchanges and discussions of project status.
Provides recommendations to clients on technical and regulatory issues.
Reviews protocols, project status reports, final study reports and other project related technical documents.
Assists business development group in technical sales and marketing, and in preparation of technical marketing materials, and presents posters and makes podium presentations at conferences.
Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.
Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP).
Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.