Labs FSP Research Scientist: LBA PK & ADA Method Development & Validation at Thermo Fisher Scientific

Lawrenceville, Georgia, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotechnology, Clinical ResearchIndustries

Requirements

Strong understanding of GLP-compliant bioanalytical workflows and method development
In-depth knowledge of global regulatory expectations (FDA, ICH, EMA) for PK and immunogenicity testing
Skilled in data interpretation and familiar with analytical/statistical software
Solid foundation in bioanalytical principles including concentration units, calibration curves, and quality controls
Proficient in laboratory operations: pipetting, balances, and digital tools
Experience with biological sample handling and automated liquid handling systems (e.g., 96-well format)
Demonstrated expertise in ligand binding assay execution and troubleshooting
Excellent written and verbal communication skills with a collaborative and solutions-focused mindset
Strong organizational skills and ability to work effectively in a cross-functional team environment

Responsibilities

Develops, validates, and implements immunoassays for the analysis of clinical and non-clinical pharmacokinetic or toxicokinetic samples in a GLP-like or GLP environment with some level of guidance
Ensure assay performance meets regulatory expectations for specificity, sensitivity, precision, accuracy, and robustness
Independently troubleshoot and optimize ligand binding PK and ADA assays to ensure robustness and reproducibility
Maintain lab inventories and order lab supplies to ensure continuity of bioanalytical activities
Utilize Watson LIMS and Electronic Lab Notebooks (ELN) for data processing, documentation, and reporting
Ensures that electronic notebooks and other documentations are up to date as per departmental guidelines
Prepare or contributes to study reports following the departmental policies and procedures
Ensures compliance with and maintains required training in BMS and departmental GLP, SOP, safety and other departmental guidelines
Achieves objectives in a manner consistent with the Core BMS Behaviors
Prepares and makes scientific presentations at internal and external meetings

Skills

Key technologies and capabilities for this role

immunoassaysbioanalytical assaysPKADANAbmethod developmentmethod validationLBAGMP

Questions & Answers

Common questions about this position

What is the work schedule for this position?

The position is full-time with a First Shift (Days) schedule.

What are the essential functions of this role?

The role involves developing, validating, and implementing immunoassays for PK, ADA, and NAb analysis in a GLP-like environment, troubleshooting and optimizing assays, maintaining lab inventories, using Watson LIMS and ELN, preparing reports, and ensuring compliance with GLP, SOP, and safety guidelines.

What specific skills or tools are required for this position?

Proficiency in developing and validating ligand binding assays for PK and ADA, troubleshooting and optimizing assays, using Watson LIMS and Electronic Lab Notebooks (ELN), and ensuring GLP compliance is required.

What is the company culture like at Thermo Fisher Scientific?

The company is passionate, deliberate, and driven by a mission to enable customers to make the world healthier, safer, and cleaner, emphasizing meaningful work, individual career goals, and adherence to Core BMS Behaviors.

What makes a strong candidate for this Research Scientist role?

A strong candidate has experience developing and validating bioanalytical immunoassays in GLP environments, can independently troubleshoot PK and ADA assays, and is skilled in lab documentation tools like Watson LIMS and ELN while ensuring regulatory compliance.

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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