Analytical CMC Lead

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

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

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