Senior Data Reviewer – Cell & Gene Therapy

Thermo Fisher Scientific

. Perform complex laboratory analysis of pharmaceutical products .

Posted 10/22/2026full-timeRemote • Wisconsin • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in laboratory analysis, method validation, and project management within the pharmaceutical industry, ensuring compliance with regulatory standards and effective communication with clients and team members.

Highest-signal resume keywords

Laboratory AnalysisMethod ValidationProject ManagementTechnical WritingRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Analytical InstrumentationData AnalysisGeneral ChemistrySeparation ScienceGMPGLPPPD SOPsICH GuidelinesUSP RequirementsTechnical Operating Systems

Soft Skills

Problem-SolvingEffective CommunicationTime ManagementTeam CollaborationMentoring

Tools & Technologies

Microsoft ExcelMicrosoft Word

Industry Keywords

Pharmaceutical ProductsBiopharmaceutical CompoundsQuality SystemsProject Status ReportsStudy Protocols

About the role

Key responsibilities & impact

Perform complex laboratory analysis of pharmaceutical products
Use analytical instrumentation and calculate, analyze and record data according to PPD SOPs and industry requirements
Act as project leader on multiple projects and interact with clients
Review and evaluate data and write reports and protocols
Lead the scientific conduct of projects and communicate regulatory issues to senior team members
Independently perform method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds
Design and drive experiments with minimal supervision
Prepare study protocols, project status reports, final study reports and technical documents
Communicate data and technical issues to clients and respond to client needs and questions
Mentor, train and coordinate laboratory activities of team members
Troubleshoot instrument and analytical problems
Assist with quality systems and new equipment
Design method validation or method transfer protocols and establish project timelines
Review, interpret and analyze data for technical quality and compliance with protocols, methods, SOPs, client criteria, GMP and GLP
Perform self and peer review of data before submission to QA and issuance to customers

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic/vocational qualification
5+ years of previous experience comparable to the role
Equivalent combination of appropriate education, training and/or directly related experience may be considered
Solid understanding of general chemistry and separation science
Full understanding of laboratory requirements, PPD and client SOPs, ICH guidelines, USP requirements and FDA guidance
Ability to use Microsoft Excel and Word
Proficiency with technical operating systems
Proven problem-solving and troubleshooting abilities
Effective oral and written communication skills
Proven technical writing skills
Time management and project management skills
Ability to work collaboratively with a team
Ability to train junior staff
Must be legally authorized to work in the United States without sponsorship
Must pass a comprehensive background check, including drug screening
Able to communicate, receive and understand information and ideas with diverse groups
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 proficiently
May be exposed to potentially hazardous elements, including infectious agents
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday-Friday work schedule
Career development resources and individual career goals support
Training and mentoring opportunities
Global impact through life-changing therapies and clinical research
Healthy and balanced work environment support