Eurofins

ELISA Method Development Scientist

Lexington, MA, US

In-personFull time roleEarly Career, Mid Level

1 day ago

About the Job

We are seeking a Scientist with expertise in plate-based process impurity assays to support biologics programs. This role will focus on the development, qualification, troubleshooting, and transfer of ELISA-based assays for detecting Host Cell Proteins (HCP), residual Protein A, residual DNA, and other process-related impurities. The ideal candidate will have hands-on experience in assay development and validation, strong analytical problem-solving skills, and the ability to collaborate with cross-functional teams.

Key Responsibilities:

1. Assay Development & Qualification (50%)

Develop, optimize, and qualify plate-based impurity assays (e.g., ELISA, qPCR, Western blot) for process impurity detection.
Evaluate assay performance, ensuring sensitivity, specificity, accuracy, and precision meet regulatory expectations.
Conduct method qualification and contribute to validation strategies in compliance with ICH and USP guidelines.
Support the development of custom and commercial HCP ELISAs, including reagent assessment and selection.

2. Assay Troubleshooting & Remediation (30%)

Investigate assay variability, drift, and reagent stability issues to ensure robust impurity testing.
Work with internal teams and external vendors/CROs to assess critical reagents and optimize assay performance.
Provide technical expertise in resolving lot-to-lot variability issues in impurity assays.
Analyze and interpret assay data, preparing technical summaries and reports.

3. Technology Transfer & Regulatory Support (20%)

Support the transfer of impurity assays to QC labs and external CRO/CDMO partners.
Prepare technical reports, regulatory submissions, and responses to health authority queries.
Participate in cross-functional meetings to ensure alignment on impurity assay strategies.

About the Company

Eurofins

Luxembourg, Luxembourg

5000 +

<div class="org-about-module__description"> <div id="ember58" class="ember-view organization-about-module__content-consistant-cards-description"><span class="lt-line-clamp__raw-line">Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is a global leader in food, environmental, pharmaceutical and cosmetic product testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. Since 1987, Eurofins has grown from one laboratory in Nantes, France to ca. 62,000 staff across a network of independent companies in 62 countries, operating over 900 laboratories. Performing over 450 million tests every year, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing. Ever since its IPO on the French stock exchange in 1997, Eurofins has been one of the fastest growing listed European companies.</span></div> </div> <div class="org-about-module__content-improvement"> <div class="org-about-module__content-box"> </div> </div>