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Thermo Fisher Scientific · 5 days ago

Senior Research Scientist - Technical Project Manager (GMP)

Middleton, WI

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

Thermo Fisher Scientific is a global leader in serving science, and they are seeking a Senior Research Scientist - Technical Project Manager to support complex client programs within a GMP laboratory environment. The role involves providing scientific oversight, mentoring junior staff, and ensuring high-quality execution across various programs.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

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

GMP environment experienceAnalytical methods expertiseTechnical writing skillsMentoring junior staffRegulatory knowledgeProject management skillsCommunicationTeam collaborationTime 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 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

Excellent written and verbal communication skills, including the ability to engage directly with clients

Full theoretical and hands-on understanding and knowledge of general chemistry and separation science

Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA mentorship

Ability to independently review and understand project proposals/plans

Ability to work in a collaborative work environment with a team

Ability to independently optimize analytical methods

Time management and project management skills