Define end-to-end analytical and control strategies that de-risk development and underpin reliable clinical and commercial supply for peptides, oligonucleotides and other new modalities
Job Summary
Define end-to-end analytical and control strategies that de-risk development and underpin reliable clinical and commercial supply for peptides, oligonucleotides and other new modalities.
Author high-quality sections of global regulatory submissions and craft clear, timely responses to questions, applying current ICH and major health authority guidance to enable approvals and post-approval changes.
Champion data-centric ways of working, leveraging digital tools, modelling and simulation, and AI-enabled approaches to improve robustness, efficiency and decision-making.
Matching Summary
Define end-to-end analytical and control strategies that de-risk development and underpin reliable clinical and commercial supply for peptides, oligonucleotides and other new modalities.
Skills & Requirements
Must-have
analytical strategy and control
method lifecycle ownership
regulatory submissions and responses
cross-functional delivery
commercialization readiness
digital and data innovation
investigation and risk reduction
Nice-to-have
advanced degree in related discipline
hands-on chromatographic expertise
QbD, DoE, and statistical techniques
late-stage development experience
direct authorship of CMC sections
familiarity with PAT and stability modelling
proficiency with digital lab systems
Key Requirements
Define and deliver analytical strategies for new modality drug products
Develop, optimise, validate, and transfer analytical methods
Author regulatory filings and respond to regulatory queries
Provide technical expertise for commercial supply
Champion data-centric ways of working
Lead root-cause investigations for OOS, OOT, and deviations