ELISA Method Development Scientist

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 .

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

Remote Work :

No

Employment Type :

Full-time