Scientist, LBA

Moderna

Oxford, United Kingdom

Moderna is seeking an experienced Bioanalytical Senior Scientist to join the Bioanalytical and Molecular Assays team to support regulated clinical trials. A successful incumbent would help integrate basic science research, bioanalysis, and informatics to move programs into the clinic as well as reverse-engineer clinical findings to novel opportunities for Moderna’s pipeline.

Here’s What You’ll Do:

Your key responsibilities will be:

Designing and executing phase-appropriate bioanalytical strategies including immunogenicity, quantitation of therapeutic proteins, lipid characterization, and PK/PD assay method development.
Ensuring assays are developed in a timely manner to meet program timelines, the qualification or validation of assays is fit for purpose, and troubleshooting any issues that arise internally or with external CRO partners.
Developing PD assays using ELISA, MSD, qPCR, ddPCR, immunoblotting, and other relevant technologies.
Establishing internal and external ASO bioanalytical capability and facilitating method development to support Moderna’s portfolio.
Managing analytical equipment procurement/qualifications, preparation and maintenance of SOPs, and control of critical reagents.

Your responsibilities will also include:

Collaborating with preclinical and clinical operations and sample management to define sample journey and develop appropriate laboratory manuals.

The key Moderna Mindsets you’ll need to succeed in the role:

Pursue options in parallel: Your role will require the ability to manage multiple tasks and projects concurrently, ensuring the best outcomes through a comprehensive approach.
Dynamic range: You will need to demonstrate the capacity to drive both strategy and execution, adapting swiftly to new data and changing priorities.

Here’s What You will Bring to the Table:

A Ph.D. in infectious disease, Immuno-oncology, Immunology, Cancer Biology, or related fields and a minimum of 3 years of industry biotech/pharmaceutical experience. M.S. with extensive bioanalytical experience (i.e. 10 years) are also considered.
Experience with RNA, biologics and cell therapy preferred.
Expert knowledge of various ligand bind binding assay platforms such as ECL, Gyrolabs, immunoassays, bDNA and other methodologies for pre-clinical and clinical assays is preferred Experience with genetic assays such as qPCR and ddPCR is a plus.
Working knowledge of the translational literature and competitive landscape in the mRNA field.
Ability to effectively communicate scientific concepts, program objectives, data analysis within a matrix environment. Knowledge of GLP and GCP requirements and understanding of current industry trends and regulatory expectations associated with bioanalytical science.

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