ELISA Method Development Scientist

Job Summary:

We are seeking a Scientist with expertise in platebased process impurity assays to support biologics programs. This role will focus on the development qualification troubleshooting and transfer of ELISAbased assays for detecting Host Cell Proteins (HCP) residual Protein A residual DNA and other processrelated impurities. The ideal candidate will have handson experience in assay development and validation strong analytical problemsolving skills and the ability to collaborate with crossfunctional teams.

Key Responsibilities:

1. Assay Development & Qualification (50%)

• Develop optimize and qualify platebased 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 lottolot 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 crossfunctional meetings to ensure alignment on impurity assay strategies.

Qualifications :

Qualifications & Experience:

• MS with 24 years or BS with 46 years of experience in Biochemistry Analytical Chemistry or a related field.
• Handson experience with ELISAbased impurity assays including HCP residual Protein A and residual DNA detection.
• Strong understanding of ligandbinding assay principles including antibodyantigen interactions signal detection and assay robustness.
• Experience troubleshooting platebased 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 businesscritical impurity assays in a highly collaborative crossfunctional environment supporting latestage and commercial biologics programs.

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

Additional Information :

• Position is fulltime Monday Friday 8:00am 5:00pm. Candidates currently living within a commutable distance of  are encouraged to apply.

• Excellent full time benefits including comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

#LIEB1

Eurofins Lancaster Laboratories Professional Scientific Services (PSS) is a global awardwinning insourcing solution that places our people at our clients site dedicated to running and managing laboratory services while eliminating headcount coemployment and projectmanagement worries.

We infuse our 55year track record of scientific and laboratory operations expertise as well as HR and 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.

Eurofins USA PSS Insourcing Solutions is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.

Remote Work :

No

Employment Type :

Fulltime