We are seeking a highly experienced CMC Consultant to support our client, a specialist life science consultancy, in the development of Lipid Nanoparticle (LNP) delivery systems for mRNA-based therapeutics. This consultant will play a key role in identifying and managing CDMO partners, guiding formulation and manufacturing strategy, and supporting mRNA experts with integration into LNP platforms.
This is a project-based, ad-hoc contract role, ideal for a specialist with deep technical expertise in LNP systems and strong knowledge of CMC requirements for mRNA-based drug products.
Responsibilities
CDMO Identification & Oversight
- Assist the client in identifying, evaluating, and selecting CDMOs for LNP development and production.
- Define and assess technical capabilities of CDMOs in:
-Encapsulation efficiency
-Targeted delivery capabilities
-Endotoxin testing
-Structure-function assessments (e.g., Zeta potential, particle size, polydispersity, etc.)
- Oversee and support CDMO relationships throughout development lifecycle.
CMC & Formulation Support
- Provide CMC input and strategic guidance on formulation development and manufacturing processes for LNP systems.
- Advise on chemistry, formulation stability, and process scalability of LNP platforms.
mRNA Integration Support
- Work closely with mRNA subject matter experts to:
-Guide loading and encapsulation strategies
-Optimise stabilisation of mRNA within LNPs
-Ensure integrity and efficiency of delivery
Requirements
- Advanced degree (PhD or MSc preferred) in Pharmaceutical Sciences, Chemistry, Biochemistry, or related field
- Extensive experience with LNP delivery systems, ideally in an mRNA therapeutic or vaccine setting
- Proven track record of CMC leadership in formulation, development, and external manufacturing
- Hands-on knowledge of critical LNP attributes such as encapsulation, zeta potential, endotoxin levels, and particle characterisation
- Experience managing or liaising with CDMOs or external partners
