Job Description
📋 Description Design, develop, optimize, and qualify cell-based bioassays for potency, lot release, and characterization. Transfer assays to GMP labs and client sites. Develop and maintain assay-ready cell lines and cell banks. Establish and evaluate assay performance attributes per ICH Q6B and USP guidance. Author, review, and maintain protocols, reports, SOPs, and documentation. Analyze data with statistical tools; present findings and provide scientific leadership. 🎯 Requirements PhD (5+ yrs) or MS (8+ yrs) or BS (12+ yrs) in related field; US work authorization. Strong experience in potency assay development, qualification, validation, and transfer for biologics. Technical expertise in cell-based bioassays, neutralizing antibody testing, ELISA, flow cytometry. Proficiency with GraphPad Prism, JMP, PLA, SoftMax Pro, or similar. Experience in CRO/CDMO or contract testing environments; client-facing collaborations. Excellent writing, communication, and project leadership with multi-project management. 🎁 Benefits Full-time Mon-Fri 8:00am-5:00pm; additional hours as needed. Medical, dental, and vision coverage. Life and disability insurance; 401(k) with company match. Paid vacation and holidays. ELNs and regulated documentation practices training.
