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Sr Data Reviewer - Small Molecule jobs in United States
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Thermo Fisher Scientific · 2 weeks ago

Sr Data Reviewer - Small Molecule

Thermo Fisher Scientific is a leading company in healthcare, and they are seeking a Senior Data Reviewer – Small Molecule. The role involves reviewing complex analytical data from pharmaceutical and biopharmaceutical compounds, ensuring compliance with GMP, SOPs, and laboratory procedures.
BiotechnologyCloud ComputingConsultingHealthcareLife ScienceEnterprise SoftwareMedical DeviceBioinformaticsCloud Data ServicesHealth CareManagement Information SystemsOffice SuppliesPrecision Medicine
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Responsibilities

Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, client directives and scientific soundness
Reviews development analyses of non-routine projects. Performs analytical data review of method qualification, verification, and validations interpreting the data for compliance and technical soundness
Performs reviews routine and non-routine protocol and methods
Facilitates in conversations with lab staff on best documentation practices and addressing quality findings
Delivers review findings noting deficiencies within the analytical data or reports in a clear and concise manner
Escalates significant deficiencies to the project leader or supervisor for assessment
Trains new Data Reviewers and laboratory staff in basic and complex analytical data review. Mentors junior data review staff in review process
Advocates the departmental manager or supervisor in the evaluation of the laboratory Data Review process and assists in assigning work to self and others
Identifies and drives process improvement initiatives
Performs other duties as assigned

Qualification

Analytical Data ReviewManufacturing Practices (GMP)Standard Operating Procedures (SOPs)Method ValidationChromatographyMethod QualificationMethod VerificationFederal Regulations GLPFederal Regulations GMPLaboratory ProceduresScientific Soundness AssessmentTraining and MentoringDocumentation Best Practices

Required

Bachelor's degree or equivalent and relevant formal academic/vocational qualification
At least 5 years' relevant experience
Strong technical knowledge of laboratory procedures, method validation, and analytical methods
Legal authorization to work in the US
Ability to pass a background check and drug screening
Excellent communication skills
Attention to detail
Ability to manage multiple priorities

Preferred

Previous experience with formal data review in GMP Lab strongly preferred
Thorough knowledge of chromatography may be required

Benefits

Fully remote role supporting GMP Laboratory in Middleton, WI
Referral bonus of 2000 USD
Ability to work in a collaborative team environment
Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process, including assistance for hearing, vision, mobility, or cognitive impairments

Company

Thermo Fisher Scientific

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Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.

Funding

Current Stage
Public Company
Total Funding
$19.77B
Key Investors
National Grid
2026-02-09Post Ipo Debt· $3.8B
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B

Leadership Team

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Marc Casper
Chairman and CEO
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Daniella Cramp
Senior Vice President and President, Bioproduction Group
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Company data provided by crunchbase