CMC Analytical Lead at Engitix Therapeutics

London, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

02 Sep, 26

Salary

0.0

Posted On

04 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical CMC Leadership, Method Development, Method Validation, CDMO Management, Biologics, Antibody-Drug Conjugates, QC Oversight, Control Strategy, Stability Strategy, IND Submissions, GMP Compliance, ICH Guidelines, Analytical Characterization, Project Management, Cross-functional Collaboration, Regulatory Affairs

Industry

Biotechnology Research

Description

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 About us Engitix is a growing biotech company based in White City Place, West London. We are dedicated to developing better therapies for advanced fibrosis and solid tumours by leveraging our pioneering extracellular matrix (ECM) platform. Our platform allows the synthesis of realistic in vitro 3D models that serve as tools to transform our ability to identify new targets and biomarkers, determine mechanisms of action and more accurately predict the efficacy of therapeutic candidates. Join us today in our mission to create a healthier future for patients with life-threatening diseases such as fibrosis and cancer.

Responsibilities

Lead analytical CMC activities for early-stage biologics and ADC programs, overseeing method development and QC activities at CDMOs. Responsible for developing control strategies, managing stability programs, and authoring analytical sections for IND regulatory submissions.