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CMC Consultant - LNP Delivery Systems

Advanced Resource Managers
Newcastle upon Tyne
3 weeks ago
Applications closed

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CMC Consultant - LNP Delivery Systems

CMC Consultant - LNP Delivery Systems

CMC Consultant - LNP Delivery Systems

Principal Consultant (CMC)

Principal Consultant (CMC)

Analytical Development Lead

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
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