Analytical CMC Lead

Company: Barrington James
Apply for the Analytical CMC Lead
Location:
Job Description:

A growing RNA therapeutics biotech is hiring a CMC Analytical Lead to drive analytical development across its early clinical pipeline.

You’ll define analytical strategies, establish robust methods, and support progression from preclinical through first-in-human studies, working closely with internal teams and external CRO/CDMO partners.

What you’ll own:

• Analytical development strategy for RNA drug substance and drug product

• Method development and optimisation across chromatographic, electrophoretic, spectrometric, and biochemical platforms

• Impurity characterisation, stability studies, and critical quality attribute definition

• CMC documentation and regulatory submission support for early clinical studies

• Method qualification, transfer, and lifecycle management in GMP environments

What we’re looking for:

• Proven experience in analytical development for RNA therapeutics or related advanced modalities

• Track record supporting early-stage IND/CTA submissions

• Familiarity with outsourced development models and GMP analytical settings

• Comfortable in a fast-paced, agile biotech environment

A high-impact role with broad scientific ownership and hands-on technical leadership. If you’re passionate about advancing RNA medicines into the clinic, we’d love to hear from you.

Posted: May 23rd, 2026