Thermo Fisher Scientific · 12 hours ago
Senior Research Scientist - Technical Project Manager (GMP)
Middleton, WI
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expThermo Fisher Scientific is a global leader in serving science, dedicated to making the world healthier, cleaner, and safer. The Senior Research Scientist will serve as a technical program lead in a GMP laboratory, providing scientific oversight and mentoring junior staff while ensuring high-quality execution across multiple programs.
Research
No H1B
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
Qualification
Required
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)
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
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
Benefits
Relocation assistance is not provided for this position
Accessibility service for job seekers requiring accommodations in the job application process
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
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