Barrington James
Analytical CMC Lead
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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.
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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
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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)
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