CMC Analytical Lead

full_time Life Scientists

Your mission

We are seeking an experienced Analytical CMC Lead to provide technical leadership for analytical activities supporting Engitix’s early-stage development programs. This role will lead analytical CMC activities, with responsibility for method development and validation, clinical release and stability, control strategy, and IND-enabling activities.

Experience supporting biologics programs is required, and experience with Antibody-Drug Conjugates (ADCs) is highly desirable.

Key Responsibilities:

• Lead analytical CMC activities for early-stage biologics and/or ADC programs, with oversight of analytical development and QC activities at CDMOs and external laboratories
• Serve as the primary analytical lead for CDMO interactions, managing technical execution, timelines, deliverables, and cross-functional coordination across CMC, quality, regulatory, manufacturing, and clinical supply teams
• Oversee analytical method ...