Scientist – Stability Data Review jobs in United States
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Thermo Fisher Scientific · 5 hours ago

Scientist – Stability Data Review

Thermo Fisher Scientific is a leading global contract research organization dedicated to making the world healthier, cleaner, and safer. The Scientist – Stability Data Review role involves technical review and reporting of commercial stability programs, ensuring compliance with cGMP standards, and generating stability reports for regulatory submission.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
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Responsibilities

Technical review and reporting of commercial stability programs
Review of technical and compliant cGMP analytical data, with focus on biologic assay
Perform data analysis and trending according to industry guidelines
Generate and provide stability reports for submission to regulatory authorities
Authors and/or reviews trending reports
Effectively communicate with internal and external stakeholders
Ensure all records adhere to cGMP/GDP expectations

Qualification

CGMP regulationsCommercial stability programsBiologics assaysStatistical softwareData analysisProject prioritizationEffective communicationAttention to detail

Required

Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ 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
Experience with commercial stability programs
Experience with statistical software and its application to support commercial stability
Knowledge of US and EU cGMP regulations/guidance
Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
Effective communication skills, both verbal and written
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

Preferred

Knowledge of biologics assays including protein concentration, potency, ELISA, SE-UPLC, CE-SDS, icIEF, qPCR are a plus

Benefits

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

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
$15.97B
Key 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

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Marc Casper
CEO
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Stephen Williamson
Senior Vice President and Chief Financial Officer
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Company data provided by crunchbase