Scientist III - HPLC, CE, GMP at Thermo Fisher Scientific

Middleton, Wisconsin, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

NoVisa

Biopharmaceutical, Pharmaceutical, Life SciencesIndustries

Requirements

Legally authorized to work in the United States without sponsorship
Ability to pass a comprehensive background check, including drug screening
Adherence to Good Manufacturing Practices (GMP) and safety standards
Ability to stand for full shift and wear PPE (safety glasses, gowning, gloves, lab coat, ear plugs, etc.)
Training on routine operation, maintenance, and theory of complex analytical instrumentation (e.g., HPLC, CE)
Knowledge of SOPs, regulatory procedures, and guidelines

Responsibilities

Independently perform routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in various formulations for stability and analytical testing
Train on and independently operate, maintain, and troubleshoot complex analytical instrumentation; mentor others in troubleshooting
Complete all laboratory documentation clearly and accurately according to SOPs and GMPs
Review and compile results, make initial determinations on acceptability per SOP criteria, and navigate OOS/OOT/Atypical investigations
Lead investigations, Root Cause Analysis, and propose CAPAs
Perform work assignments accurately, timely, and safely; independently manage QC responsibilities
Communicate project status to project leader, identify gaps, and anticipate roadblocks in project workflow
Coordinate laboratory activities of other team members in conjunction with the lab supervisor
Assist with study design and protocol authoring; lead data evaluation and study close-out
Independently complete QA-facing tasks and author/lead complex quality records

Skills

Key technologies and capabilities for this role

HPLCCEGMPCapillary ElectrophoresisHigh-Performance Liquid ChromatographyGood Manufacturing PracticesAnalytical ChemistryBiopharmaceutical AnalysisLaboratory TechniquesQuality Control

Questions & Answers

Common questions about this position

Is this position remote or onsite?

This is a fully onsite role based at our GMP Laboratory in Middleton, WI, and we welcome applicants from all locations within the US.

What are the key skills required for the Scientist III role?

The role requires experience with HPLC and CE techniques, adherence to GMP standards, proficiency in routine to complex sample preparation and analysis of pharmaceutical and biopharmaceutical compounds, and ability to train on complex analytical instrumentation, SOPs, and regulatory guidelines.

What is the work schedule for this position?

The work schedule is First Shift (Days), involving standing for the full shift in a GMP environment with some PPE required.

What is the company culture like at Thermo Fisher Scientific?

The company emphasizes meaningful work that positively impacts global health, provides resources for career goals, and fosters commitment to accuracy, quality, and innovation through teams of scientists and industry thought-leaders.

What should I know before applying for this role?

Candidates must be legally authorized to work in the US without sponsorship, able to pass a comprehensive background check including drug screening, and responsible for any relocation costs as assistance is not provided.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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