Barrington James
Analytical CMC Lead
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Role Overview
A growing biotechnology company developing RNA-based therapeutics is seeking an experienced CMC Analytical Lead to support advancement of its pipeline into early clinical development.
This is a high-impact role focused on leading analytical development activities across innovative nucleic acid therapeutics and associated delivery technologies. The successful candidate will play a key role in defining analytical strategies, establishing robust methodologies, and supporting progression from preclinical development through regulatory submission and first-in-human studies.
Operating within a collaborative and fast-paced environment, this position offers broad scientific ownership alongside hands-on technical leadership, working closely with internal teams and external development partners.
Key Responsibilities
Analytical Development & Strategy
- Define and execute analytical development strategies for RNA-based drug substance and drug product programs
- Establish methods to evaluate identity, purity, potency, stability, and critical quality attributes
- Develop and optimize phase-appropriate analytical approaches for nucleic acid therapeutics
- Apply a range of analytical techniques including chromatographic, electrophoretic, spectrometric, and biochemical assays
- Design impurity characterization and control strategies for both process- and product-related impurities
- Lead stability and degradation studies to support formulation development and product understanding
- Support analytical troubleshooting, method lifecycle management, and technical transfer activities
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Regulatory & Clinical Readiness
- Support activities associated with regulatory submissions for early clinical studies
- Oversee qualification and transfer of analytical methods into compliant external laboratory environments
- Contribute to preparation of CMC documentation and technical briefing materials
- Assist in defining specifications and analytical control strategies across development stages
- Support interactions and responses related to regulatory review activities
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Cross-Functional Collaboration
- Partner closely with research, process development, formulation, and quality teams to ensure integrated development plans
- Manage external CRO and CDMO relationships supporting analytical and CMC activities
- Provide scientific leadership across multidisciplinary project teams
Ideal Background
- Strong experience in analytical development for RNA therapeutics, or related advanced therapeutic modalities
- Expertise across a broad range of analytical characterization techniques
- Experience supporting early-stage clinical development and regulatory submissions
- Familiarity with outsourced development models and GMP analytical environments
- Comfortable operating within an agile and rapidly evolving biotech setting
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