ELISA Method Development Scientist

Eurofins Viracor BioPharma Services; Lexington (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

Eurofins Viracor BioPharma Services is seeking a qualified Scientist specializing in plate-based process impurity assays to manage the development and transfer of ELISA-based assays for biologics programs. As part of a collaborative team, you will address assay challenges while ensuring compliance with regulatory standards. This full-time position offers the chance to significantly contribute to advanced biologics testing, with competitive benefits and opportunities for professional growth.

Benefits

Comprehensive medical coverage

Dental and vision options

401(k) with company match

Paid vacation and holidays

Qualifications

• 2-4 years (MS) or 4-6 years (BS) in related field.
• Hands-on experience with ELISA-based assays.
• Strong understanding of ligand-binding assay principles.

Responsibilities

• Develop, optimize, and qualify plate-based impurity assays.
• Investigate assay variability and ensure robust testing.
• Support transfer of impurity assays to QC labs.

Skills

Analytical Problem Solving

Collaboration

Assay Development

Troubleshooting

Education

MS in Biochemistry or Analytical Chemistry

BS in Biochemistry or Analytical Chemistry

Tools

SoftMax Pro

JMP

Job description

1 week ago Be among the first 25 applicants

Company Description

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.

• 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.
• 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.
• 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.
  
  

• Full-time
  
  

Company Description

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

• 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.
• 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.
• 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.

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