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Thermo Fisher Scientific · 9 hours ago

Research Scientist - Technical Project Manager (GMP)

Middleton, WI

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Thermo Fisher Scientific is a leader in serving science, dedicated to making the world healthier, cleaner, and safer. In this role, you will oversee analytical testing and study activities in a GMP-regulated laboratory, ensuring compliance with quality standards while managing multiple studies and acting as a client-facing technical resource.

Research

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

GMP knowledgeRoot cause analysisTechnical writingAnalytical methods optimizationProject managementEffective communicationProblem solvingMentoringTime management

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)

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

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 technical writing skills

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