CMC Analytical Lead

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 development, qualification, transfer, and lifecycle management for drug substance and drug product programs
• Provide analytical oversight of QC activities including release and stability testing, characterization, reference standards, investigations, deviations, and change controls
• Develop phase-appropriate analytical control strategies, including specification setting and justification, to support clinical development and regulatory requirements
• Lead stability strategy and data review to support shelf-life and retest period assignments
• Review analytical data to support process development, comparability, process characterization, investigations, and regulatory submissions
• Author and review analytical CMC sections for INDs and other regulatory submissions, including specifications, analytical methods, qualification/validation summaries, comparability, and stability documentation
• Support regulatory interactions and ensure analytical activities comply with GMP, ICH, and global regulatory expectations
• Identify analytical and operational risks related to external execution and implement mitigation strategies to support program timelines and milestones

Your profile

• Advanced degree (M.S., Ph.D.) in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline preferred
• 8+ years experience in analytical development within biologics, large molecule, or bioconjugate CMC environments, or equivalent
• Strong expertise in analytical characterization techniques for proteins and biologics
• Experience overseeing QC testing, analytical outsourcing, and CDMO management
• Demonstrated experience with analytical method development, qualification, transfer, and troubleshooting
• Experience supporting stability programs, specification setting, and control strategy development
• Working knowledge of early-phase regulatory expectations and IND-enabling activities
• Experience authoring and reviewing analytical sections of IND submissions
• Experience with ADCs is a strong plus
• Experience with small-molecule analytics, including linker-payload characterization, is a plus
• Strong project management, communication, and cross-functional collaboration skills

Why us?

• Be part of a pioneering biotech transforming drug discovery through ECM biology
• Work in a collaborative, fast-paced environment with opportunities to shape the future of targeted therapeutics
• We offer a competitive package including private medical insurance, pension, bonus, employee perks and more