Quality Control Analyst - 259267

Experienced Quality Control Analyst – Bioassays & ELISAs (Gaithersburg, MD)

Join a dynamic and growing biopharma company in Gaithersburg, MD seeking an experienced QC Analyst with expertise in quantitative bioassays and ELISA routine testing to ensure biopharmaceutical products meet rigorous quality and functional performance specifications.

Position Duration: Open-ended, ongoing contract role with strong potential to convert to permanent staff.

Work Schedule: Standard business hours, Monday–Friday

Responsibilities:

• Ensure biopharmaceutical quality through routine functional bioassay testing in support of cGMP manufacturing operations.
• Execute ELISA-based bioassays to evaluate target-binding affinity, relative biological activity, and antibody reactivity across product lots.
• Conduct cell culture, cell-based assays, residuals, etc. for product release and stability.
• Document test results in strict accordance with cGMP standards and laboratory SOPs.
• Collaborate closely with cross-functional teams within the QC bioassay laboratory.
• Perform peer review of bioassay datasets and analytical calculations.
• Root-cause investigations and troubleshooting for ELISA methods, assay drift, standard curves, and laboratory instrumentation as needed.
• Mentor and train junior analysts as needed.

Qualifications:

• Education: Bachelor of Science in Biology or similar scientific discipline.
• Experience: 2 to 5 years of conducting ELISAs in a regulated Quality Control (GMP) or Bioanalytical (GLP) laboratory, with at least 2 years hands-on experience running routine ELISA methods.
• Key Expertise: Track record of conducting quantitative ELISA bioassays, dose-response curves, relative activity determinations, or receptor-binding assays.
• Strong experience cell culture and pipetting skills are required.
• Troubleshooting: Experience troubleshooting bioassay methods is preferred.