ELISA Method Development Scientist

Eurofins PSS Insourcing Solutions; Lexington (MA); On-site; USD 70,000 - 100,000; Full time

Job summary

Eurofins PSS Insourcing Solutions is seeking a Scientist to develop and qualify impurity assays for biologics programs. The role involves hands-on assay development, troubleshooting, and regulatory support in a collaborative environment. Join a leading company committed to professional growth and work-life balance.

Benefits

Comprehensive medical coverage

401(k) with company match

Paid vacation and holidays

Qualifications

• 2-4 years experience with ELISA-based impurity assays.
• Hands-on experience in assay development and validation.
• Knowledge of ICH/FDA regulatory guidelines.

Responsibilities

• Develop and qualify plate-based impurity assays.
• Troubleshoot assay variability and reagent stability.
• Support technology transfer to QC labs.

Skills

Analytical problem-solving

Assay development

Collaboration

Education

MS in Biochemistry or Analytical Chemistry

BS in Biochemistry or Analytical Chemistry

Tools

SoftMax Pro

JMP

Job description

2 days ago Be among the first 25 applicants

The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

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 our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, 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 believes it is a global leader in food, environmental, pharmaceutical and cosmetics products 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.

If you’re looking for a rewarding career, apply with us today!

The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

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 our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, 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 believes it is a global leader in food, environmental, pharmaceutical and cosmetics products 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.

If you’re looking for a rewarding career, apply with us today!

Job Description

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.
  
  

Qualifications

Authorization to work in the United States indefinitely without restriction or sponsorship

• MS with 2-4 years or BS with 4-6 years of experience in Biochemistry, Analytical Chemistry, or a related field.
• Hands-on experience with ELISA-based impurity assays, including HCP, residual Protein A, and residual DNA detection.
• Strong understanding of ligand-binding assay principles, including antibody-antigen interactions, signal detection, and assay robustness.
• Experience troubleshooting plate-based assays and resolving reagent variability issues.
• Knowledge of ICH/FDA regulatory guidelines for impurity testing in biologics.

Preferred Skills:

• Familiarity with SoftMax Pro, JMP, or other data analysis tools.
• Experience with custom antibody development for ELISA assays.
• Knowledge of critical reagent lifecycle management for impurity assays.
• Experience with method qualification and transfer in a GMP environment.

This role offers an exciting opportunity to work on business-critical impurity assays in a highly collaborative, cross-functional environment supporting late-stage and commercial biologics programs.

Additional Information

The position is full-time and permanent, Monday-Friday, 8 am-5 pm, with overtime as needed. Candidates living near or in Lexington, MA, are encouraged to apply.

Excellent full-time benefits include:

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins Lancaster Laboratories Professional Scientific Services (PSS) is a global, award-winning insourcing solution that places our people at our clients’ sites, dedicated to running and managing laboratory services while eliminating headcount, co-employment, and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR, and a great place to work best practices, to recruit, hire, train, and manage highly qualified scientists to perform laboratory services using our clients’ quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com.

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Hospitals and Health Care, Non-profit Organizations, and Government Administration

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