Tech Stack

Description

You will lead analytical development activities for biologics programs, including monoclonal antibodies, from early to late phase. Your work involves designing methods, managing CRO/CDMO partnerships, and supporting regulatory filings to advance novel therapies.

Requirements

• PhD in Analytical Chemistry, Biochemistry, or related field with 7+ years industry experience
• Expertise in analytical methods for monoclonal antibodies (mass spec, H/UPLC, CE-SDS, icIEF)
• Experience with ELISA, bioassay, and potency assays preferred
• Proven ability to manage external CRO/CDMO partnerships
• Strong problem-solving and project management skills

Responsibilities

• Design, develop, and implement analytical methods for biologics characterization
• Manage experiments for developability screening, process development, and comparability studies
• Develop analytical strategies ensuring regulatory compliance
• Collaborate cross-functionally to support project goals
• Author and review regulatory submission sections (IND, BLA, MAA)