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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