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