Senior Scientist, Analytical Development

📋 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.