Senior Research Associate, BMA

Role Summary

Senior Research Associate in Moderna's Bioanalytical and Molecular Assay team focused on GLP/GCP bioanalytical LC-MS/MS for a range of molecules, supporting method development, validation, and sample analysis in clinical studies.

Responsibilities

• Develop, optimize, validate, and run bioanalytical LC/MS methods for quantitation of various types of molecules, particularly lipids, biomarkers, and proteins (peptides)
• Draft study plans, bioanalytical methods, and study reports
• Conduct bioanalytical assays following established protocols and SOPs, in compliance with GLP/GCP guidelines
• Coordinate with external CROs on method development, qualifications, and validations; review and approval SOWs, protocols, and reports
• Work closely with colleagues in Clinical Development as well as cross-functional groups
• Provide mass spectrometry support to scientists in Clinical Development, Platform, and other groups
• Stay abreast of literature, government guidelines, internal guidance on clinical trial conduct including GLP, GCP, internal SOPs and regulations for pre-clinical and clinical bioanalysis

Qualifications

• Bachelor’s degree with at least 5+ years laboratory experience or MS with 3+ years of hands-on experience with development and validation of bioanalytical methods using LC-MS
• Hands-on experience with sample preparation/extraction techniques for various analytes from biological matrices such as SPE, LLE, protein precipitation. CRO experience is a plus
• Ability to develop and implement methods for high throughput or (semi-)automated data analysis (e.g. Hamilton/Tecan automation)
• Experience with Electronic Lab Notebooks
• Willingness to learn new concepts and adaptability to change
• Organization and attention to detail; ability to handle multiple projects in a fast-paced environment
• Strong interpersonal skills with an eagerness to work with and support colleagues in other departments
• Proven ability to develop and work independently and to collaborate cross-functionally to accomplish goals in a timely manner
• Must have work authorization in the US without the need for future sponsorship