Analytical CMC Lead

The Opportunity

A rapidly emerging biotechnology company developing RNA-based therapeutics is seeking a CMC analytical lead to support the progression of its pipeline toward IND/CTA submission and early clinical studies.

This is a high-impact role responsible for shaping the analytical development strategy for complex oligonucleotide-based drug candidates, including conjugated delivery systems targeting the central nervous system. The successful candidate will play a key role in building the analytical framework, methodologies, and quality approach required to advance novel therapeutics from preclinical development into the clinic.

Operating within a lean, fast-paced environment, this position offers the opportunity to combine strategic ownership with hands-on scientific input, working closely with both internal teams and external partners.

Key Responsibilities

Analytical Development & Strategy

• Define and execute the CMC analytical strategy for oligonucleotide drug substance and drug product
• Establish methods to assess identity, purity, potency, stability, and critical quality attributes
• Develop phase-appropriate analytical techniques for RNA-based therapeutics and conjugated systems
• Apply a range of analytical platforms, including HPLC (IP-RP), IEX, SEC, CE, LC-MS/MS, and spectroscopic and cell-based assays
• Design impurity profiling strategies, addressing both process- and product-related impurities
• Lead forced degradation and stability studies to understand degradation pathways and inform shelf-life

Regulatory & IND/CTA Readiness

• Support IND/CTA-enabling activities, ensuring analytical methods align with regulatory expectations
• Oversee method qualification and transfer into GMP-compliant environments
• Contribute to regulatory documentation, including CMC sections of IND/IMPD submissions and briefing packages
• Define specifications for drug substance and drug product across development stages
• Support responses to health authority queries (e.g. MHRA, FDA)