Thermo Fisher Scientific · 14 hours ago
Research Scientist - Technical Project Manager (GMP)
Middleton, WI
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expThermo Fisher Scientific is a global leader in serving science, and they are seeking a Research Scientist - Technical Project Manager to support pharmaceutical and biopharmaceutical client programs in a GMP-regulated laboratory. The role involves overseeing analytical testing, managing multiple studies, and ensuring compliance with quality standards while mentoring team members.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
No H1B
Responsibilities
Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines
Independently performs and provides guidance on complex sample preparation and analytical procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds across a variety of formulations and matrices for stability and analytical testing
Completes all laboratory documentation clearly, accurately, and compliantly, in accordance with SOPs, GMP, and GLP requirements, with a strong emphasis on high-quality technical writing
Leads advanced troubleshooting for various equipment & instruments
Reviews and compiles results from assignments and makes determination on acceptability per SOP acceptance criteria. Reviews overall study results
Navigates the OOS/OOT/Atypical investigation process. Leads more complex investigations and Root Cause Analysis and leads CAPAs
Independently manages QC responsibilities. Communicates project status to project leader and helps to address gaps and solutions to overcoming roadblocks in project team workflow. May act as project leader
Coordinates and supervises laboratory activities of other team members in conjunction with lab management
Performs study design & protocol authoring. Leads data evaluation and study close-out
Independently completes QA facing tasks. Authors and leads more complex quality records (eg. quality records which may require more in-depth investigation to identify true root causes, quality records requiring cross-departmental input and/or collation of data etc.)
Mentors other staff members in applicable areas
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 8+ 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 technical and quality writing skills, including authoring protocols, reports, and quality records in GMP environment
Intermediate knowledge of relevant scientific principles applicable to role
Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA mentorship
Full knowledge of technical operating systems
Ability to independently optimize analytical methods
Ability to independently perform root cause analysis for method investigations
Proven problem solving and troubleshooting abilities
Effective written and oral communication skills as well as presentation skills
Time management and project management skills
Ability to mentor others on technical operating systems
Ability to independently review and understand project proposals/plans
Ability to work in a collaborative work environment with a team
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
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
Business Standard India
2026-01-14
2026-01-14
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