Associate Director, Immunogenicity and Ligand Binding Assays

Moderna

Oxford, United Kingdom

The Role:

Moderna is seeking an experienced Bioanalytical and Molecular Sciences expert to join the Clinical Bioanalytical team to lead Immunogenicity and LBA-based bioanalysis under GLP/GcLP compliance. A successful incumbent will provide Scientific and operational oversight of pharmacokinetic (PK), anti-drug antibodies, neutralizing antibody assays and routine biomarker bioanalyses for Moderna mRNA based therapeutic pipeline. This role will be based at the new Moderna Innovation and Technology Centre in Harwell – the first Moderna research centre outside of the USA – and is an opportunity to join an exciting, dynamic, and expanding team.

Here’s What You’ll Do:

Leads the Immunogenicity and Ligand Binding Assays team and the design and execution of phase-appropriate clinical bioanalytical strategies, including quantitation of therapeutic proteins, immunogenicity (anti- drug antibodies and neutralizing antibody assays) and PK/PD assay method development, validation and sample testing under GLP/GcLP regulations;
Establish LBA based GLP/GCLP regulated capability and facilitate method development and validation to support clinical programs. Responsible for in-house GLP/GCLP infrastructure, systems and procedures to ensure adequate rigorous laboratory practices & regulatory requirements for analytical activities assuring phase appropriate approach;
Responsible for the development of cell based Nab assays and PD assays using ELISA, MSD, multiplex LBAs, and Gyro based protein assays, immunoblotting and other relevant technologies;
Responsible to ensure assays are developed in a timely manner to meet program timelines, the qualification or validation of assays is fit for purpose in clinical use and troubleshoot any issues that arise internally or with external CRO partners;
Responsibilities also include analytical equipment procurement/qualifications, preparation and maintenance of SOP’s, determination, and control of critical reagents for example;
Assist in writing regulatory submissions and in responding to regulatory queries when needed;
Stay abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), internal SOPs and regulations and White Papers, as appropriate, for clinical bioanalysis to ensure practices are consistent with regulatory expectations.

Here’s What You’ll Bring to the Table:

A Ph.D., or equivalent qualifications and experience, in infectious disease, Immuno-oncology, Immunology, Cancer Biology, or related fields and a minimum of 7+ years of industry biotech/pharmaceutical experience in regulated bioanalysis;
Experience with RNA, biologics and cell therapy preferred;
Expert knowledge of various ligand bind binding assay platforms such as ECL, Gyrolabs, cell based assays and other methodologies for pre-clinical and clinical assays is preferred;
Ability to effectively communicate scientific concepts, program objectives, data analysis within a matrix environment;
Knowledge of GLP requirements and understanding of current industry trends and regulatory expectations associated with analytical science.

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