Senior Scientist, Bioassay Development

Job Summary

A company is looking for a Remote Senior Scientist, Bioassay Development.

Key Responsibilities

• Define and execute bioassay development strategies for various biologics
• Direct the development, optimization, qualification, and transfer of potency assays
• Oversee the preparation of regulatory-supporting documents and ensure compliance

Required Qualifications

• Advanced degree (PhD or MS with equivalent experience) in a relevant field
• 10+ years of industry experience in bioassay development, including 3+ years in leadership
• Expertise in cell-based and binding assay platforms
• Experience with mammalian cell culture and bioassay development in a CMC setting preferred
• Strong track record in assay transfer, qualification, and regulatory documentation