Analytical Bioassay Consultant

Overview

Job Title: Analytical Bioassay Consultant

Employment Type: Contract (W2 Only)

We are seeking an experienced Analytical Bioassay Consultant to support cell-based bioassays in a GMP-regulated laboratory. The ideal candidate will have strong expertise in mammalian cell culture
, ELISA
, and execution of validated bioassays while ensuring compliance with GMP documentation and quality standards.

• Execute validated cell-based potency and functional bioassays under GMP guidelines
• Perform mammalian cell culture, including aseptic techniques, passaging, and viability monitoring
• Conduct ELISA and other analytical bioassays
• Follow SOPs, test methods, and GMP documentation requirements
• Identify, document, and report deviations or atypical results
• Support assay troubleshooting and continuous process improvement
• Maintain accurate laboratory records and ensure compliance with regulatory requirements

• Bachelor's or Master's degree in Biology, Biotechnology, Biochemistry, Microbiology, or related Life Sciences field
• 3+ years of experience in a GMP-regulated laboratory
• Hands-on experience with mammalian cell culture and cell-based bioassays
• Experience executing validated analytical or bioassay methods
• Strong knowledge of ELISA techniques
• Excellent understanding of GMP, SOP compliance, and controlled documentation
• Strong analytical, organizational, and communication skills

• Experience in pharmaceutical or biotechnology QC laboratories
• Familiarity with assay qualification and validation activities
• Knowledge of FDA regulations and cGMP requirements
• Experience supporting investigations and deviation management